Botulinum injections for hand tremor
Phase 2
Completed
- Conditions
- Health Condition 1: null- Dystonic hand tremorHealth Condition 2: G252- Other specified forms of tremor
- Registration Number
- CTRI/2018/02/011721
- Lead Sponsor
- All India Institute of Medical Sciences New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
a)Age >18 years
b)Isolated focal/segmental/multifocal dystonia having brachial dystonia with dystonic tremor as defined by the Movement Disorder Society Consensus criteria for tremor (1998)(3)
c)On stable dose of medications for tremor (if any) for the past 1 month prior to study enrolment
d)Not previously received BoNT for hand dystonia/tremor or last injection at least 4 months prior to study enrolment
Exclusion Criteria
a)Clinical evidence of Parkinsonism, cerebellar ataxia
b)Hand tremor associated with dystonia in another body part and absent focal hand dystonia (Tremor associated with dystonia)
c)Contraindications to BoNT:Neuromuscular junction disorder, anterior horn cell disorder
d)Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total score on Fahn-Tolosa-Marin scale at 6 weeks after the intervention session.Timepoint: 6 weeks
- Secondary Outcome Measures
Name Time Method Fahn-Tolosa-Marin tremor rating scale Part A component for the upper extremity, Part B for specific motor tasks and Part C for functional disabilities resulting from tremorTimepoint: 6 weeks, 12 weeks;Patient Global Impression of Change scaleTimepoint: 6 weeeks, 12 weeks;Total power of the spectrum on tremor analysisTimepoint: 6 weeks;Writerâ??s Cramp Rating Scale total scoreTimepoint: 6 weeks, 12 weeks