Page last updated: 2024-10-24

caffeine and Hyperactivity, Motor

caffeine has been researched along with Hyperactivity, Motor in 25 studies

Research

Studies (25)

TimeframeStudies, this research(%)All Research%
pre-199019 (76.00)18.7374
1990's1 (4.00)18.2507
2000's4 (16.00)29.6817
2010's1 (4.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Linnet, KM1
Wisborg, K1
Secher, NJ1
Thomsen, PH1
Obel, C1
Dalsgaard, S1
Henriksen, TB1
Park, KS1
Eun, JS1
Kim, HC1
Moon, DC1
Hong, JT1
Oh, KW1
Castellanos, FX1
Rapoport, JL3
Coitinho, AS1
Dietrich, MO1
Hoffmann, A1
Dall'Igna, OP1
Souza, DO1
Martins, VR1
Brentani, RR1
Izquierdo, I1
Lara, DR1
Gerlach, J1
Kruesi, MJ2
Krummel, DA1
Seligson, FH1
Guthrie, HA1
Bunt, C1
Towbin, R1
Bhatara, V1
Arnold, LE2
Knopp, W1
Smeltzer, DJ2
Reichard, CC1
Elder, ST1
Harvey, DH1
Marsh, RW1
Christopher, J1
Huestis, R1
Conners, CK1
Schechter, MD1
Firestone, P2
Poitras-Wright, H1
Douglas, V1
Davey, J1
Goodman, JT1
Peters, S1
Furlong, FW1
Garfinkel, BD1
Webster, CD1
Sloman, L1
Gross, MD1
Schnackenberg, RC2
Pulvirenti, L1
Swerdlow, NR1
Koob, GF1
Panchenko, EN1
Fras, I1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Pharmacological Treatment of Rett Syndrome by Stimulation of Synaptic Maturation With Recombinant Human IGF-1(Mecasermin [rDNA] Injection)[NCT01777542]Phase 230 participants (Actual)Interventional2013-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Aberrant Behavior Checklist - Community Edition (ABC-C)

"The ABC-C is a global behavior checklist implemented for the measurement of drug and other treatment effects in populations with intellectual disability. Behavior based on 58 items that describe various behavioral problems.~Each item is rated on the parents perceived severity of the behavior. The answer options for each item are:~0 = Not a problem~= Problem but slight in degree~= Moderately serious problem~= Severe in degree~The measure is broken down into the following subscales with individual ranges as follows:~Subscale I (Irritability): 15 items, score range = 0-45 Subscale II (Lethargy): 16 items, score range = 0-48 Subscale III (Stereotypy): 7 items, score range = 0-21 Subscale IV (Hyperactivity): 16 items, score range = 0-48 Subscale V (Inappropriate Speech) was not included in the breakdown because it was not applicable (no participants in the study had verbal language)." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First Intervention: Subscale IVisit 3 - First Intervention: Subscale IVisit 5 - First Intervention: Subscale IVisit 6 - Second Intervention: Subscale IVisit 8 - Second Intervention: Subscale IVisit 10 - Second Intervention: Subscale IFollow-up: Subscale I (Irritability)Visit 1 - First Intervention: Subscale IIVisit 3 - First Intervention: Subscale IIVisit 5 - First Intervention: Subscale IIVisit 6 - Second Intervention: Subscale IIVisit 8 - Second Intervention: Subscale IIVisit 10 - Second Intervention: Subscale IIFollow-up: Subscale II (Lethargy)Visit 1 - First Intervention: Subscale IIIVisit 3 - First Intervention: Subscale IIIVisit 5 - First Intervention: Subscale IIIVisit 6 - Second Intervention: Subscale IIIVisit 8 - Second Intervention: Subscale IIIVisit 10 - Second Intervention: Subscale IIIFollow-up: Subscale III (Stereotypy)Visit 1 - First Intervention: Subscale IVVisit 3 - First Intervention: Subscale IVVisit 5 - First Intervention: Subscale IVVisit 6 - Second Intervention: Subscale IVVisit 8 - Second Intervention: Subscale IVVisit 10 - Second Intervention: Subscale IVFollow-up: Subscale IV (Hyperactivity)
Placebo First, Then rhIGF-19.009.007.007.004.005.003.0013.0011.009.0011.008.006.006.0013.0010.0011.0011.0010.008.008.0013.0012.0011.0011.007.0010.009.00
rhIGF-1 First, Then Placebo6.004.002.004.003.005.002.008.007.006.005.005.004.005.0012.0010.009.0011.009.009.009.008.008.006.007.004.005.005.00

Anxiety, Depression, and Mood Scale (ADAMS)

"Remaining subscales of the ADAMS that are not primary outcome measures include: Manic/hyperactive, Depressed mood, General anxiety, Obsessive/compulsive behavior.~The range for each subscale is as follows:~Manic/Hyperactive Behavior: 0-15 Depressed Mood: 0-21 General Anxiety: 0-21 Obsessive/Compulsive Behavior: 0-9~The higher the score for each subscale, the more problematic the behavior." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1- First Intervention: Manic/HyperactiveVisit 2- First Intervention: Manic/HyperactiveVisit 3- First Intervention: Manic/HyperactiveVisit 4- First Intervention: Manic/HyperactiveVisit 5- First Intervention: Manic/HyperactiveVisit 6- Second Intervention: Manic/HyperactiveVisit 7- Second Intervention: Manic/HyperactiveVisit 8- Second Intervention: Manic/HyperactiveVisit 9- Second Intervention: Manic/HyperactiveVisit 10- First Intervention: Manic/HyperactiveFollow-up: Manic/Hyperactive SubscaleVisit 1- First Intervention: Depressed MoodVisit 2- First Intervention: Depressed MoodVisit 3- First Intervention: Depressed MoodVisit 4- First Intervention: Depressed MoodVisit 5- First Intervention: Depressed MoodVisit 6- Second Intervention: Depressed MoodVisit 7- Second Intervention: Depressed MoodVisit 8- Second Intervention: Depressed MoodVisit 9- Second Intervention: Depressed MoodVisit 10- Second Intervention: Depressed MoodFollow-up: Depressed Mood SubscaleVisit 1- First Intervention: General AnxietyVisit 2- First Intervention: General AnxietyVisit 3- First Intervention: General AnxietyVisit 4- First Intervention: General AnxietyVisit 5- First Intervention: General AnxietyVisit 6- Second Intervention: General AnxietyVisit 7- Second Intervention: General AnxietyVisit 8- Second Intervention: General AnxietyVisit 9- Second Intervention: General AnxietyVisit 10- Second Intervention: General AnxietyFollow-up: General Anxiety SubscaleVisit 1- First Intervention: Obsessive CompulsiveVisit 2- First Intervention: Obsessive CompulsiveVisit 3- First Intervention: Obsessive CompulsiveVisit 4- First Intervention: Obsessive CompulsiveVisit 5- First Intervention: Obsessive CompulsiveVisit 6- Second Intervention: Obsessive CompulsiveVisit 7- Second Intervention: Obsessive CompulsiveVisit 8- Second Intervention: Obsessive CompulsiveVisit 9- Second Intervention: Obsessive CompulsiveVisit 10- First Intervention: Obsessive CompulsiveFollow-up: Obsessive Compulsive Behavior Subscale
Placebo First, Then rhIGF-18.007.007.007.007.008.006.506.006.005.005.002.004.003.002.002.002.003.002.003.002.002.008.006.006.005.005.006.006.006.004.004.005.504.004.004.003.003.003.003.003.003.002.003.50
rhIGF-1 First, Then Placebo7.007.006.005.004.006.005.005.004.004.505.004.005.003.003.004.004.003.003.002.003.003.506.007.006.005.005.007.005.004.003.004.004.003.004.004.003.003.003.003.003.002.002.503.00

Anxiety, Depression, and Mood Scale (ADAMS) - Social Avoidance Subscale

"The ADAMS is completed by the parent/caregiver/LAR and consists of 29 items which are scored on a 4-point rating scale that combines frequency and severity ratings. The instructions ask the rater to describe the individual's behavior over the last six months on the following scale: 0 if the behavior has not occurred, 1 if the behavior occurs occasionally or is a mild problem, 2 if the behavior occurs quite often or is moderate problem, or 3 if the behavior occurs a lot or is a severe problem.~The Social Avoidance subscale of the ADAMS will be used as a primary outcome measure for this trial. The range for this subscale is 0-21. The higher the subscale score, the more problematic the behavior." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-16.005.005.006.005.004.004.004.003.003.504.00
rhIGF-1 First, Then Placebo4.005.004.004.003.004.004.004.003.003.503.00

Clinical Global Impression - Improvement (CGI-I)

"Each time the patient was seen after the study intervention was initiated, the clinician compared the patient's overall clinical condition to the CGI-S score obtained at the baseline (visit 1) visit. Based on information collected, the clinician determined if any improvement occurred on the following 7-point scale: 1=Very much improved since the initiation of treatment; 2=Much improved; 3=Minimally improved; 4=No change from baseline (the initiation of treatment); 5=Minimally worse; 6=Much worse; 7=Very much worse since the initiation of treatment.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 10 weeks during each of the two 20-week treatment periods

,
Interventionunits on a scale (Median)
Visit 3 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 8 - Second InterventionVisit 10 - Second Intervention
Placebo First, Then rhIGF-14.004.004.004.004.00
rhIGF-1 First, Then Placebo4.004.004.004.004.00

Clinical Global Impression - Severity (CGI-S)

"This scale is used to judge the severity of the subject's disease prior to entry into the study. The clinician will rate the severity of behavioral symptoms at baseline on a 7-point scale from not impaired to the most impaired.~The scores that correspond to each possible grouping are as follows: 1=Normal, not at all impaired; 2=Borderline impaired; 3=Mildly impaired; 4=Moderately impaired; 5=Markedly impaired; 6=Severely impaired; 7=The most impaired.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 10 weeks during each of the two 20-week treatment periods

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 3 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 8 - Second InterventionVisit 10 - Second Intervention
Placebo First, Then rhIGF-14.004.004.004.004.004.00
rhIGF-1 First, Then Placebo4.004.004.004.004.004.50

Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP)

"The CSBS-DP was designed to measure early communication and symbolic skills in infants and young children (that is, functional communication skills of 6 month to 2 year olds). The CSBS-DP measures skills from three composites: (a) Social (emotion, eye gaze, and communication); (b) Speech (sounds and words); and (c) Symbolic (understanding and object use) and asks about developmental milestones. The data reported are the composite scores for these three categories.~The possible scores for the three composite categories are as follows:~Social Composite = 0-48; Speech Composite = 0-40; Symbolic Composite = 0-51.~A higher score indicates more advanced abilities in that area." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First Intervention: SocialVisit 2: Social Composite ScoreVisit 3: Social Composite ScoreVisit 4: Social Composite ScoreVisit 5: Social Composite ScoreVisit 6 - Second Intervention: SocialVisit 7 - Second Intervention: SocialVisit 8 - Second Intervention: SocialVisit 9 - Second Intervention: SocialVisit 10 - Second Intervention: SocialFollow-up: Social Composite ScoreVisit 1 - First Intervention: SpeechVisit 2 - First Intervention: SpeechVisit 3 - First Intervention: SpeechVisit 4 - First Intervention: SpeechVisit 5 - First Intervention: SpeechVisit 6 - Second Intervention: SpeechVisit 7 - Second Intervention: SpeechVisit 8 - Second Intervention: SpeechVisit 9 - Second Intervention: SpeechVisit 10 - Second Intervention: SpeechFollow-up: Speech Composite ScoreVisit 1 - First Intervention: SymbolicVisit 2 - First Intervention: SymbolicVisit 3 - First Intervention: SymbolicVisit 4 - First Intervention: SymbolicVisit 5 - First Intervention: SymbolicVisit 6 - Second Intervention: SymbolicVisit 7 - Second Intervention: SymbolicVisit 8 - Second Intervention: SymbolicVisit 9 - Second Intervention: SymbolicVisit 10 - Second Intervention: SymbolicFollow-up: Symbolic Composite Score
Placebo First, Then rhIGF-119.0020.0018.0018.0020.0018.0020.0021.0021.0022.5022.504.003.005.005.506.504.004.005.005.005.006.009.5010.5010.5012.0011.5013.0010.2511.5011.5013.7514.25
rhIGF-1 First, Then Placebo22.0024.0024.0024.0023.0028.0025.0027.0029.0027.0028.007.005.008.005.008.008.507.006.505.007.256.0014.0014.5015.0014.0016.5018.5017.0017.0018.0017.0018.00

Kerr Clinical Severity Scale

"The Kerr clinical severity scale (Kerr scale) is a quantitative measure of global disease severity. The Kerr scale is a summation of individual items related to Rett syndrome phenotypic characteristics. The items are based on the severity or degree of abnormality of each characteristic on a discrete scale (0, 1, 2) with the highest level corresponding to the most severe or most abnormal presentations.~The possible range of scores is 0-48. The higher the score, the more severe the symptoms." (NCT01777542)
Timeframe: At the start and end of each 20-week treatment period

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 10 - Second Intervention
Placebo First, Then rhIGF-116.5015.0015.0014.00
rhIGF-1 First, Then Placebo18.0018.0019.0020.00

Mullen Scales of Early Learning (MSEL)

"The MSEL is a standardized developmental test for children ages 3 to 68 months consisting of five subscales: gross motor, fine motor, visual reception, expressive language, and receptive language.~The raw score is reported for each subscale domain. The potential score ranges are as follows:~Visual Reception: 33 items, score range=0-50, Fine Motor: 30 items, score range= 0-49, Receptive Language: 33 items, score range= 0-48, Expressive Language: 28 items, score range= 0-50. The gross motor subscale was not included in this population.~A higher raw score indicates more advanced abilities in that section." (NCT01777542)
Timeframe: At the start and end of each 20-week treatment period

,
Interventionunits on a scale (Median)
Visit 1- First Intervention: Visual ReceptionVisit 5- First Intervention: Visual ReceptionVisit 6- Second Intervention: Visual ReceptionVisit 10: Visual Reception Raw ScoreVisit 1- First Intervention: Fine MotorVisit 5- First Intervention: Fine MotorVisit 6- Second Intervention: Fine MotorVisit 10- Second Intervention: Fine MotorVisit 1- First Intervention: Receptive LanguageVisit 5- First Intervention: Receptive LanguageVisit 6- Second Intervention: Receptive LanguageVisit 10- Second Intervention: Receptive LanguageVisit 1- First Intervention: Expressive LanguageVisit 5- First Intervention: Expressive LanguageVisit 6- Second Intervention: Expressive LanguageVisit 10- Second Intervention: Expressive Language
Placebo First, Then rhIGF-117.0026.0023.0028.0010.009.0011.009.0020.0030.0031.0031.008.009.006.008.00
rhIGF-1 First, Then Placebo26.0039.5042.0044.007.007.0010.008.5025.5032.0038.0036.509.008.0010.008.00

Parent Targeted Visual Analog Scale (PTSVAS) - Scale 1

"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-16.504.705.655.054.804.954.555.654.154.805.60
rhIGF-1 First, Then Placebo8.804.805.355.105.155.204.655.005.155.055.08

Parent Targeted Visual Analog Scale (PTSVAS) - Scale 2

"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-17.754.505.855.005.005.355.505.153.804.905.15
rhIGF-1 First, Then Placebo6.355.255.955.405.457.105.855.005.134.955.20

Parent Targeted Visual Analog Scale (PTSVAS) - Scale 3

"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-17.854.705.654.155.006.204.804.854.604.134.55
rhIGF-1 First, Then Placebo5.705.005.205.355.105.354.955.155.254.555.10

Parental Global Impression - Improvement (PGI-I)

"As part of each visit after the study intervention was initiated, the parent/caregiver was asked to compare the patient's overall clinical condition to the score obtained at the baseline (visit 1) visit. Based on information collected, the clinician determined if any improvement occurred on the following 7-point scale: 1=Very much improved since the initiation of treatment; 2=Much improved; 3=Minimally improved; 4=No change from baseline (the initiation of treatment); 5=Minimally worse; 6=Much worse; 7=Very much worse since the initiation of treatment.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-14.003.003.003.004.003.003.003.003.003.00
rhIGF-1 First, Then Placebo4.004.004.003.003.003.003.003.003.003.00

Parental Global Impression - Severity (PGI-S)

"The PGI-S is the parent version of the CGI-S. Parents/caregivers/LAR are asked to rate the severity of their child's symptoms at baseline on a 7-point scale from not at all impaired to the most impaired. The parents/caregivers/LAR will complete the PGI-S at each study visit.~The scores that correspond to each possible grouping are as follows:~1=Normal, not at all impaired; 2=Borderline impaired; 3=Mildly impaired; 4=Moderately impaired; 5=Markedly impaired; 6=Severely impaired; 7=The most impaired.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-14.004.004.004.004.004.004.004.004.004.004.00
rhIGF-1 First, Then Placebo6.004.004.004.004.004.004.006.006.005.004.00

Quantitative Measures of Respiration: Apnea Index

"Respiratory data was collected using non-invasive respiratory inductance plethysmography from a BioCapture® recording device. BioCapture® is a child-friendly measurement device that can record from 1 to 12 physiological signal transducers in a time-locked manner. It can be configured with the pediatric chest and abdominal plethysmography bands and the 3 lead ECG signals we plan to use for monitoring cardiac safety throughout the study. Each transducer is placed on the patient independently to provide a customized fit that yields the highest signal quality for each patient irrespective of body shape and proportion. The transducer signals captured by the BioCapture® are transmitted wirelessly to a laptop computer where all signals are displayed in real-time.~The apnea index is given as apneas/hour. Data on apneas greater than or equal to 10 seconds are displayed below. The higher the frequency of apnea, the more severe the breathing abnormality." (NCT01777542)
Timeframe: Every 10 weeks during each of the two 20-week treatment periods

,
InterventionApneas/Hour (Median)
Visit 1 - First Intervention: Apnea IndexVisit 3 - First Intervention: Apnea IndexVisit 5 - First Intervention: Apnea IndexVisit 6 - Second Intervention: Apnea IndexVisit 8 - Second Intervention: Apnea IndexVisit 10 - Second Intervention: Apnea Index
Placebo First, Then rhIGF-17.584.806.937.907.288.91
rhIGF-1 First, Then Placebo4.053.483.073.625.555.56

Rett Syndrome Behavior Questionnaire (RSBQ)

"The RSBQ is a parent-completed measure of abnormal behaviors typically observed in individuals with RTT. Each item, grouped into eight subscales, is scored on a Likert scale of 0-2, according to how well the item describes the individual's behavior. A score of 0 indicates the described item is not true, a score of 1 indicates the described item is somewhat or sometimes true, and a score of 2 indicates the described item is very true or often true.~The total sum of each subscale is reported. The higher the score, the more severe the symptoms of that subscale in the participant.~The range for each subscale is as follows:~General Mood: 0-16 Body rocking and expressionless face: 0-14 Hand behaviors: 0-12 Breathing Problems: 0-10 Repetitive Face Movements: 0-8 Night-time behaviors: 0-6 Walking Standing: 0-4~The fear/anxiety subscale was used as a primary outcome measure in this study and results can be found in that section." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1- First Intervention: General MoodVisit 2- First Intervention: General MoodVisit 3- First Intervention: General MoodVisit 4- First Intervention: General MoodVisit 5- First Intervention: General MoodVisit 6- Second Intervention: General MoodVisit 7- Second Intervention: General MoodVisit 8- Second Intervention: General MoodVisit 9- Second Intervention: General MoodVisit 10- Second Intervention: General MoodFollow-up: General MoodVisit 1- First Intervention: Body RockingVisit 2- First Intervention: Body RockingVisit 3- First Intervention: Body RockingVisit 4- First Intervention: Body RockingVisit 5- First Intervention: Body RockingVisit 6- Second Intervention: Body RockingVisit 7- Second Intervention: Body RockingVisit 8- Second Intervention: Body RockingVisit 9- Second Intervention: Body RockingVisit 10- Second Intervention: Body RockingFollowup: Body RockingVisit 1- First Intervention: Hand BehaviorsVisit 2- First Intervention: Hand BehaviorsVisit 3- First Intervention: Hand BehaviorsVisit 4- First Intervention: Hand BehaviorsVisit 5- First Intervention: Hand BehaviorsVisit 6- Second Intervention: Hand BehaviorsVisit 7- Second Intervention: Hand BehaviorsVisit 8- Second Intervention: Hand BehaviorsVisit 9- Second Intervention: Hand BehaviorsVisit 10- Second Intervention: Hand BehaviorsFollow-up: Hand BehaviorsVisit 1- First Intervention: Breathing ProblemsVisit 2- First Intervention: Breathing ProblemsVisit 3- First Intervention: Breathing ProblemsVisit 4- First Intervention: Breathing ProblemsVisit 5- First Intervention: Breathing ProblemsVisit 6- Second Intervention: Breathing ProblemsVisit 7- Second Intervention: Breathing ProblemsVisit 8- Second Intervention: Breathing ProblemsVisit 9- Second Intervention: Breathing ProblemsVisit 10- Second Intervention: Breathing ProblemsFollow-up: Breathing ProblemsVisit 1- First Intervention: Repetitive Face MovemVisit 2- First Intervention: Repetitive Face MovemVisit 3- First Intervention: Repetitive Face MovemVisit 4- First Intervention: Repetitive Face MovemVisit 5- First Intervention: Repetitive Face MovemVisit 6- Second Intervention: Repetitive Face MovVisit 7- Second Intervention: Repetitive Face MovVisit 8- Second Intervention: Repetitive Face MovVisit 9- Second Intervention: Repetitive Face MovVisit 10- Second Intervention: Repetitive Face MovFollow-up: Repetitive Face MovementsVisit 1- First Intervention: Night time BehaviorsVisit 2- First Intervention: Night time BehaviorsVisit 3- First Intervention: Night time BehaviorsVisit 4- First Intervention: Night time BehaviorsVisit 5- First Intervention: Night time BehaviorsVisit 6- Second Intervention: Night time BehaviorVisit 7- Second Intervention: Night time BehaviorVisit 8- Second Intervention: Night time BehaviorVisit 9- Second Intervention: Night time BehaviorVisit 10- Second Intervention: Night time BehaviorFollow-up: Night time BehaviorsVisit 1- First Intervention: Walking/StandingVisit 2- First Intervention: Walking/StandingVisit 3- First Intervention: Walking/StandingVisit 4- First Intervention: Walking/StandingVisit 5- First Intervention: Walking/StandingVisit 6- Second Intervention: Walking/StandingVisit 7- Second Intervention: Walking/StandingVisit 8- Second Intervention: Walking/StandingVisit 9- Second Intervention: Walking/StandingVisit 10- Second Intervention: Walking/StandingFollow-up: Walking/Standing
Placebo First, Then rhIGF-17.005.006.005.005.004.005.505.006.004.005.506.005.005.006.005.004.005.005.004.005.004.508.009.008.008.008.009.008.008.008.007.007.506.004.005.005.005.006.004.506.005.006.005.002.002.003.002.003.003.003.003.003.003.002.000.000.000.000.000.000.000.001.000.000.000.002.002.002.002.002.002.002.002.003.001.502.00
rhIGF-1 First, Then Placebo4.003.002.002.003.004.002.002.001.002.502.004.004.003.004.004.004.003.004.003.004.004.008.008.008.009.009.008.009.009.007.009.008.504.004.004.005.004.004.003.003.003.004.003.002.002.003.002.002.003.002.002.002.001.502.001.001.000.000.001.001.000.000.000.000.000.002.002.002.002.002.002.002.002.002.002.002.00

Rett Syndrome Behavior Questionnaire (RSBQ) - Fear/Anxiety Subscale

"The RSBQ is an informant/parent-completed measure of abnormal behaviors typically observed in individuals with RTT, which is completed by a parent/caregiver/LAR. Each item, grouped into eight domains/factors: General mood, Breathing problems, Body rocking and expressionless face, Hand behaviors, Repetitive face movements, Night-time behaviors, Fear/anxiety and Walking/standing), is scored on a Likert scale of 0-2, according to how well the item describes the individual's behavior. A score of 0 indicates the described item is not true, a score of 1 indicates the described item is somewhat or sometimes true, and a score of 2 indicates the described item is very true or often true.~The total sum of items in each subscale is reported.~For the fear/anxiety subscale, the sum total could be between 0-8. The higher the sum total score, the greater the frequency of fear/anxiety behaviors." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-14.005.004.004.003.004.004.003.003.004.003.50
rhIGF-1 First, Then Placebo5.003.003.003.003.004.003.004.003.003.003.50

Vineland Adaptive Behavior Scales, Second Edition (VABS-II)

"The VABS-II is a survey designed to assess personal and social functioning. Within each domain (Communication, Daily Living Skills, Socialization, and Motor Skills), items can given a score of 2 if the participant successfully performs the activity usually; a 1 if the participant successfully performs the activity sometimes, or needs reminders; a 0 if the participant never performs the activity, and a DK if the parent/caregiver is unsure of the participant's ability for an item.~The raw scores in each sub-domain are reported and the ranges for these are as follows: [Communication Domain], Receptive Language=0-40, Expressive Language=0-108, Written Language=0-50; [Daily Living Skills Domain], Personal=0-82, Domestic=0-48, Community=0-88; [Socialization Domain], Interpersonal Relationships=0-76, Play and Leisure Time=0-62, Coping Skills=0-60; [Motor Skills Domain]: Gross Motor Skills=0-80, Fine Motor Skills=0-72.~A higher score indicates more advanced abilities." (NCT01777542)
Timeframe: At the start and end of each 20-week treatment period

,
Interventionunits on a scale (Median)
Visit 1 - First Intervention: ReceptiveVisit 5 - First Intervention: ReceptiveVisit 6 - Second Intervention: Receptive LanguageVisit 10 - Second Intervention: Receptive LanguageVisit 1 - First Intervention: ExpressiveVisit 5 - First Intervention: ExpressiveVisit 6 - Second Intervention: Expressive Lang.Visit 10 - Second Intervention: Expressive Lang.Visit 1 - First Intervention: WrittenVisit 5 - First Intervention: WrittenVisit 6: - Second Intervention Written LanguageVisit 10 - Second Intervention: Written LanguageVisit 1 - First Intervention: PersonalVisit 5 - First Intervention: PersonalVisit 6 - Second Intervention: PersonalVisit 10 - Second Intervention: PersonalVisit 1 - First Intervention: DomesticVisit 5 - First Intervention: DomesticVisit 6 - Second Intervention: DomesticVisit 10 - Second Intervention: DomesticVisit 1 - First Intervention: CommunityVisit 5 - First Intervention: CommunityVisit 6 - Second Intervention: CommunityVisit 10 - Second Intervention: CommunityVisit 1 - First Intervention: Interpersonal Rel.Visit 5 - First Intervention: Interpersonal Rel.Visit 6 - Second Intervention: Interpersonal Rel.Visit 10 - Second Intervention: Interpersonal Rel.Visit 1 - First Intervention: Play and LeisureVisit 5 - First Intervention: Play and LeisureVisit 6 - Second Intervention: Play and LeisureVisit 10 - Second Intervention: Play and LeisureVisit 1 - First Intervention: Coping SkillsVisit 5 - First Intervention: Coping SkillsVisit 6 - Second Intervention: Coping SkillsVisit 10 - Second Intervention: Coping SkillsVisit 1 - First Intervention: Gross MotorVisit 5 - First Intervention: Gross MotorVisit 6 - Second Intervention: Gross MotorVisit 10 - Second Intervention: Gross MotorVisit 1 - First Intervention: Fine MotorVisit 5 - First Intervention: Fine MotorVisit 6 - Second Intervention: Fine MotorVisit 10 - Second Intervention: Fine Motor
Placebo First, Then rhIGF-113.0015.0018.0020.0016.0017.0018.0020.000.000.004.006.009.0010.009.0010.000.000.000.000.000.001.001.002.0018.0018.0019.0020.008.0011.0012.0011.003.002.003.004.0031.0034.0027.0027.006.006.007.005.00
rhIGF-1 First, Then Placebo18.0021.0022.0024.5018.0022.0025.0024.004.005.007.007.008.009.008.509.500.000.000.000.003.003.005.005.0021.0022.0021.0022.5013.0012.0013.0012.503.004.006.004.5010.0010.0011.5010.502.003.004.004.00

Reviews

5 reviews available for caffeine and Hyperactivity, Motor

ArticleYear
Effects of caffeine on development and behavior in infancy and childhood: a review of the published literature.
    Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 2002, Volume: 40, Issue:9

    Topics: Adolescent; Caffeine; Central Nervous System Stimulants; Child; Child Behavior; Child Development; C

2002
Behavior and nutrition: a mini review.
    Boletin de la Asociacion Medica de Puerto Rico, 1984, Volume: 76, Issue:9

    Topics: Adult; Behavior; Caffeine; Child; Child Behavior; Criminal Psychology; Dietary Carbohydrates; Educat

1984
Hyperactivity: is candy causal?
    Critical reviews in food science and nutrition, 1996, Volume: 36, Issue:1-2

    Topics: Attention Deficit Disorder with Hyperactivity; Cacao; Caffeine; Candy; Child; Child, Preschool; Fema

1996
Possible psychiatric significance of excessive coffee consumption.
    Canadian Psychiatric Association journal, 1975, Volume: 20, Issue:8

    Topics: Adult; Anxiety Disorders; Blood Pressure; Caffeine; Canada; Cardiovascular System; Cerebrovascular C

1975
Diet and human behavior: how much do they affect each other?
    Annual review of nutrition, 1986, Volume: 6

    Topics: Amino Acids; Aspartame; Behavior; Caffeine; Carbohydrates; Child; Child, Preschool; Circadian Rhythm

1986

Trials

7 trials available for caffeine and Hyperactivity, Motor

ArticleYear
A survey study of the use of electropupillogram in predicting response to psychostimulants.
    Psychopharmacology, 1978, Apr-28, Volume: 57, Issue:2

    Topics: Adolescent; Caffeine; Central Nervous System Stimulants; Child; Child, Preschool; Dextroamphetamine;

1978
The effects of caffeine on reaction time in hyperkinetic and normal children.
    The American journal of psychiatry, 1977, Volume: 134, Issue:2

    Topics: Attention; Caffeine; Child; Choice Behavior; Clinical Trials as Topic; Discrimination, Psychological

1977
The effects of de-caffeinated coffee versus whole coffee on hyperactive children.
    Developmental medicine and child neurology, 1978, Volume: 20, Issue:1

    Topics: Attention; Caffeine; Child; Clinical Trials as Topic; Coffee; Double-Blind Method; Female; Humans; H

1978
Methylphenidate vs dextroamphetamine vs caffeine in minimal brain dysfunction: controlled comparison by placebo washout design with Bayes' analysis.
    Archives of general psychiatry, 1978, Volume: 35, Issue:4

    Topics: Attention Deficit Disorder with Hyperactivity; Caffeine; Child; Child, Preschool; Clinical Trials as

1978
The acute effects of caffeine on evoked response, vigilance, and activity level in hyperkinetic children.
    Journal of abnormal child psychology, 1979, Volume: 7, Issue:2

    Topics: Alpha Rhythm; Attention; Caffeine; Child; Dose-Response Relationship, Drug; Electroencephalography;

1979
Methylphenidate and caffeine in the treatment of children with minimal brain dysfunction.
    The American journal of psychiatry, 1975, Volume: 132, Issue:7

    Topics: Administration, Oral; Attention Deficit Disorder with Hyperactivity; Caffeine; Child; Clinical Trial

1975
Caffeine in the treatment of children with minimal brain dysfunction or hyperkinetic syndrome.
    Psychosomatics, 1975, Volume: 16, Issue:1

    Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Caffeine; Child; Child, Preschool; Clinic

1975

Other Studies

13 other studies available for caffeine and Hyperactivity, Motor

ArticleYear
Coffee consumption during pregnancy and the risk of hyperkinetic disorder and ADHD: a prospective cohort study.
    Acta paediatrica (Oslo, Norway : 1992), 2009, Volume: 98, Issue:1

    Topics: Adolescent; Adult; Attention Deficit Disorder with Hyperactivity; Caffeine; Central Nervous System S

2009
(-)-Epigallocatethin-3-O-gallate counteracts caffeine-induced hyperactivity: evidence of dopaminergic blockade.
    Behavioural pharmacology, 2010, Volume: 21, Issue:5-6

    Topics: Animals; Caffeine; Catechin; Central Nervous System Stimulants; Hyperkinesis; Male; Mice; Mice, Inbr

2010
Decreased hyperlocomotion induced by MK-801, but not amphetamine and caffeine in mice lacking cellular prion protein (PrP(C)).
    Brain research. Molecular brain research, 2002, Nov-15, Volume: 107, Issue:2

    Topics: Amphetamine; Animals; Caffeine; Dizocilpine Maleate; Dopamine Agonists; Down-Regulation; Excitatory

2002
[Legalized koffinautin abuse].
    Ugeskrift for laeger, 1981, May-04, Volume: 143, Issue:19

    Topics: Caffeine; Epilepsy; Histamine H1 Antagonists; Humans; Hyperkinesis; Psychoses, Substance-Induced; Su

1981
Treatment of pentobarbitol sodium (Nembutal) hyperactivity: a new approach.
    Pediatric radiology, 2000, Volume: 30, Issue:3

    Topics: Caffeine; Carbonated Beverages; Child; Humans; Hyperkinesis; Hypnotics and Sedatives; Pentobarbital

2000
Caffeine potentiation of amphetamine: implications for hyperkinesis therapy.
    Pharmacology, biochemistry, and behavior, 1977, Volume: 6, Issue:3

    Topics: Animals; Caffeine; Dextroamphetamine; Dose-Response Relationship, Drug; Drug Synergism; Humans; Hype

1977
The effects of caffeine on hyperactive children.
    Journal of learning disabilities, 1978, Volume: 11, Issue:3

    Topics: Caffeine; Child; Child Behavior; Child, Preschool; Female; Humans; Hyperkinesis; Male; Time and Moti

1978
The effects of caffeine and methylphenidate on hyperactive children.
    Journal of the American Academy of Child Psychiatry, 1978,Summer, Volume: 17, Issue:3

    Topics: Caffeine; Child; Double-Blind Method; Drug Evaluation; Female; Humans; Hyperkinesis; Male; Methylphe

1978
Caffeine therapy for hyperkinetic children.
    Current psychiatric therapies, 1975, Volume: 15

    Topics: Caffeine; Child; Humans; Hyperkinesis

1975
Microinjection of a glutamate antagonist into the nucleus accumbens reduces psychostimulant locomotion in rats.
    Neuroscience letters, 1989, Aug-28, Volume: 103, Issue:2

    Topics: Amphetamine; Analysis of Variance; Animals; Caffeine; Cocaine; Dose-Response Relationship, Drug; Exc

1989
Caffeine as a substitute for Schedule II stimulants in hyperkinetic children.
    The American journal of psychiatry, 1973, Volume: 130, Issue:7

    Topics: Caffeine; Child; Humans; Hyperkinesis; Male; Methylphenidate; Stimulation, Chemical

1973
[Treatment of extrapyramidal hyperkinesis].
    Vrachebnoe delo, 1973, Volume: 7, Issue:7

    Topics: Adolescent; Adult; Ambulatory Care; Basal Ganglia Diseases; Benzimidazoles; Benzyl Compounds; Bromin

1973
Letter: Alternating caffeine and stimulants.
    The American journal of psychiatry, 1974, Volume: 131, Issue:2

    Topics: Caffeine; Child, Preschool; Coffee; Dextroamphetamine; Humans; Hyperkinesis; Male

1974