Page last updated: 2024-10-25

dantrolene and Stroke

dantrolene has been researched along with Stroke in 3 studies

Dantrolene: Skeletal muscle relaxant that acts by interfering with excitation-contraction coupling in the muscle fiber. It is used in spasticity and other neuromuscular abnormalities. Although the mechanism of action is probably not central, dantrolene is usually grouped with the central muscle relaxants.
dantrolene : The hydrazone resulting from the formal condensation of 5-(4-nitrophenyl)furfural with 1-aminohydantoin. A ryanodine receptor antagonist used for the relief of chronic severe spasticity and malignant hyperthermia.

Stroke: A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)

Research Excerpts

ExcerptRelevanceReference
"Background and Purpose- Intrathecal baclofen (ITB) is an effective treatment for managing patients with severe poststroke spasticity, who can experience continued pain and decline in their quality of life (QoL)."9.27Effect of Intrathecal Baclofen on Pain and Quality of Life in Poststroke Spasticity. ( Abouihia, A; Calabrese, A; Cloud, G; Creamer, M; Francisco, GE; Kossmehl, P; Saltuari, L; Ward, AB; Wissel, J; Yochelson, M; Zampolini, M, 2018)
"Background and Purpose- Intrathecal baclofen (ITB) is an effective treatment for managing patients with severe poststroke spasticity, who can experience continued pain and decline in their quality of life (QoL)."5.27Effect of Intrathecal Baclofen on Pain and Quality of Life in Poststroke Spasticity. ( Abouihia, A; Calabrese, A; Cloud, G; Creamer, M; Francisco, GE; Kossmehl, P; Saltuari, L; Ward, AB; Wissel, J; Yochelson, M; Zampolini, M, 2018)

Research

Studies (3)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's1 (33.33)29.6817
2010's2 (66.67)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Creamer, M1
Cloud, G1
Kossmehl, P1
Yochelson, M1
Francisco, GE1
Ward, AB1
Wissel, J1
Zampolini, M1
Abouihia, A1
Calabrese, A1
Saltuari, L1
Lipták, J1
Yelnik, AP1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized, Controlled, Open-label, Parallel-group, Multi-center Study to Compare the Effect of Intrathecal Baclofen Therapy Versus Best Medical Treatment on Severe Spasticity in Post-stroke Patients After 6 Months Active Treatment[NCT01032239]Phase 461 participants (Actual)Interventional2009-11-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6

Change in average 10MTWT from baseline to month 6 beetween ITB and BMT arm. Change=10MTWT at month 6 - 10MTWT at baseline (NCT01032239)
Timeframe: Baseline and month 6

Interventionseconds (Mean)
ITB Therapy4.86
Best Medical Treatment (BMT)-2.48

Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6

"AS is a manual test, measuring the resistance to passive movement about a joint with varying degrees of velocity. Scores range from 1-5, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. The following muscle groups in the lower extremities were assessed: hip flexors, hip adductors, knee extensors, knee flexors, plantar flexors and ankle-dorsal flexors. Average AS was calculated as the average of AS scores of the 6 muscles of the affected lower extremity. Change in average AS in affected lower extremities from baseline to month 6 between ITB and BMT arm was assessed.~Change= AS at month 6 - AS at baseline." (NCT01032239)
Timeframe: Baseline and month 6

Interventionunits on a scale (Mean)
ITB Therapy-0.99
Best Medical Treatment (BMT)-0.43

Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to Month 6

"AS is a manual test, measuring the resistance to passive movement about a joint with varying degrees of velocity. Scores range from 1-5, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. The following muscle groups in the upper extremities were assessed: wrist flexors, elbow flexors, elbow extensors, shoulder abductors and shoulder adductors. Average AS was calculated as the average of AS scores of the 5 muscles of the affected lower extremities. Change in average AS in affected upper extremities from baseline to month 6 between ITB and BMT arm was assessed.~Change= AS at month 6 - AS at baseline." (NCT01032239)
Timeframe: Baseline and month 6

Interventionunits on a scale (Mean)
ITB Therapy-0.66
Best Medical Treatment (BMT)-0.17

Change in Functional Independence Measure (FIM) Score From Baseline to Month 6

FIM contains 18 items composed of 13 motor tasks and 5 cognitive tasks. Tasks are rated on a 7-point ordinal scale that ranges from total assistance (or complete dependence) to complete independence. Ratings should reflect actual observed performance, not capability. Total score ranges from 18 (lowest) to 126 (highest) level of independence. Change in FIM total score from baseline to month 6 between ITB and BMT arm was assessed. Change=FIM score at month 6 - FIM score at baseline. (NCT01032239)
Timeframe: Baseline and month 6

Interventionunits on a scale (Mean)
ITB Therapy2.68
Best Medical Treatment (BMT)-2.58

Change in Stroke Specific Quality of Life (SS-QoL ) From Baseline to Month 6

"SS-QoL questionnaire is a self-assessed quality of life questionnaire specifically designed for post-stroke patients. It evaluates 49 items across 12-domains: personality, energy, language, mobility, vision, upper extremity function, thinking, mood, work/productivity, self-care, and family and social roles. Each item is rated on a 5-point Likert Scale, measuring either positive or negative response to a statement. Summary score is composed of an unweighted average of the 12 domain scores, with higher scores indicating better QoL. Total score ranges from 1 to 5. Change in SS-QoL summary score from baseline to month 6 between ITB and BMT arm was assessed.~Change=SS-QoL score at month 6 - SS-QoL score at baseline." (NCT01032239)
Timeframe: Baseline and month 6

Interventionunits on a scale (Mean)
ITB Therapy0.26
Best Medical Treatment (BMT)0.05

Change in Euro QoL Group-5 Dimensional, 3 Level Version (EQ-5D-3L) From Baseline to Month 6

"The EQ-5D-3L is a generic measure of health status consisting in the EQ-5D-3L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system is characterized on five dimensions: mobility, self-care, ability to undertake usual activities, pain and anxiety/depression. Patients were asked to indicate their level of health on each dimension using one of three levels: no health problems, moderate health problems, and severe health problems. Responses from the questionnaire were converted to a single health index utility score; this ranges from -0.595 to 1. EQ VAS records the patient's self-rated health on a vertical visual analogue scale from 0 to 100 where the endpoints are labelled 'Best imaginable health state' (100) and 'Worst imaginable health state' (0). Change in EQ-5D-3L utility score and VAS score from baseline to month 6 between ITB and BMT arm were assessed. Change=EQ-5D-3L utility or VAS score at month 6 - EQ-5D-3L utility or VAS score." (NCT01032239)
Timeframe: Baseline and month 6

,
Interventionunits on a scale (Mean)
Utility ScoreVAS
Best Medical Treatment (BMT)0.014.40
ITB Therapy0.099.68

Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6

"NPRS is designed to assess the level of pain a patient is feeling at a point in time. The following questions has been presented to patients: What is your actual spasticity-related or spasm-related pain? What was your least spasticity-related or spasm-related pain during the last week? What was your worst spasticity-related or spasm-related pain during the last week? The patient indicated how much pain he is feeling on a scale from 0 to 10. A score of 0 (zero) is no pain while a score of 10 (ten) is worst possible pain. Change in NPRS related to actual, least or worst pain from baseline to month 6 between ITB and BMT arm was assessed. Change=NPRS at month 6 - NPRS at baseline." (NCT01032239)
Timeframe: Baseline and month 6

,
Interventionunits on a scale (Mean)
Actual painLeast PainWorst Pain
Best Medical Treatment (BMT)0.000.24-0.04
ITB Therapy-1.17-1.61-1.35

Change in SF-12 (12-item Short Form) From Baseline to Month 6

The SF-12 is generic assessment of health-related quality of life, which evaluates 8 health dimensions (physical functioning, role physical, bodily pain, vitality, social functioning, role emotional, mental health, and general health). Subscale scores for each dimension were aggregated into summary scores for physical (PCS) and mental health (MCS) components (ranging from 0 to 100, with higher scores indicating better health). Changes in the PCS and MCS from baseline to Month 6 were both compared between the BMT and ITB arms. Change=SF-12 score at month 6 - SF-12 score at baseline. (NCT01032239)
Timeframe: Baseline and month 6

,
Interventionunits on a scale (Mean)
PCSMCS
Best Medical Treatment (BMT)-1.13-0.82
ITB Therapy3.131.05

Healthcare Resource Utilization

Number of patients with healthcare professional contacts outside of study visits in the ITB and BMT between baseline and months 6 (NCT01032239)
Timeframe: baseline, ITB test (only ITB arm), second assessment (only BMT arm), week 6 (only ITB arm), month 3, month 6

,
InterventionParticipants (Count of Participants)
Baseline : general practitionerBaseline : neurologistBaseline : nurse (hospital setting)Baseline : nurse (home care)Baseline : orthopedic surgeonBaseline : otherITB test:general practitionerITB test: neurologistITB test :otherSecond Assessment: general practitionerSecond Assessment: neurologistSecond Assessment: nurse (home care)Second Assessment: otherweek 6: general practitionerweek 6: nurse (hospital setting)week 6: othermonth 3: general practitionermonth 3: neurologistmonth 3: othermonth 6: general practitionermonth 6: neurologistmonth 6: other
Best Medical Treatment (BMT)8801013NANANA5114NANANA8397211
ITB Therapy14410310113NANANANA422716838

Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance

Patient was asked to transfer from the wheelchair to bed without human assistance. High level functional patient (HLP) could transfer. Low level functional patient (LLP) was not able to transfer. Comparison of the number and percentage of HLP and LLP between ITB and BMT arms was evaluated. (NCT01032239)
Timeframe: baseline, month 3, month 6

InterventionParticipants (Count of Participants)
Baseline72364475Baseline72364476Month 372364475Month 372364476Month 672364475Month 672364476
HLPLLP
ITB Therapy22
Best Medical Treatment (BMT)24
ITB Therapy9
Best Medical Treatment (BMT)21
ITB Therapy6
ITB Therapy19
Best Medical Treatment (BMT)19
ITB Therapy5
Best Medical Treatment (BMT)5

Therapy Satisfaction

"Patients were presented with two statements (I am satisfied with the reduction in spasticity provided by my treatment, and I would recommend this therapy to a friend). They agreed, disagreed or were neutral with the statements." (NCT01032239)
Timeframe: month 6

InterventionParticipants (Count of Participants)
Patient Satisfaction with Spasticity Reduction72364475Patient Satisfaction with Spasticity Reduction72364476Patient Therapy Reccomandation72364475Patient Therapy Reccomandation72364476
disagreeneutralagree
ITB Therapy2
Best Medical Treatment (BMT)7
ITB Therapy4
ITB Therapy16
Best Medical Treatment (BMT)11
Best Medical Treatment (BMT)5
ITB Therapy3
Best Medical Treatment (BMT)4
Best Medical Treatment (BMT)14

Reviews

1 review available for dantrolene and Stroke

ArticleYear
[Pharmacology and upper limb poststroke spasticity: a review. International Society of Prosthetics and Orthotics].
    Annales de readaptation et de medecine physique : revue scientifique de la Societe francaise de reeducation fonctionnelle de readaptation et de medecine physique, 2004, Volume: 47, Issue:8

    Topics: Arm; Baclofen; Botulinum Toxins, Type A; Clonidine; Combined Modality Therapy; Dantrolene; Ergonomic

2004

Trials

1 trial available for dantrolene and Stroke

ArticleYear
Effect of Intrathecal Baclofen on Pain and Quality of Life in Poststroke Spasticity.
    Stroke, 2018, Volume: 49, Issue:9

    Topics: Administration, Oral; Aged; Baclofen; Benzodiazepines; Clonidine; Dantrolene; Female; Humans; Infusi

2018

Other Studies

1 other study available for dantrolene and Stroke

ArticleYear
[Comparative effectiveness of different muscle relaxants in the rehabilitation of post-stroke patients with spasticity].
    Ideggyogyaszati szemle, 2013, Nov-30, Volume: 66, Issue:11-12

    Topics: Aged; Baclofen; Clonidine; Comparative Effectiveness Research; Dantrolene; Female; Humans; Male; Mus

2013