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Botulinum injections for hand tremor

Botulinum toxin injection for treatment of dystonic hand tremor: a randomised, placebo-controlled, parallel group trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/011721
Enrollment
30
Registered
2018-02-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Dystonic hand tremor Health Condition 2: G252- Other specified forms of tremor

Interventions

Intervention1: Botulinum toxin: Botulinum toxin (50U of Onabotulinum Toxin A or equivalent) will be injected intramuscularly into the dystonic/ tremulous muscles under electromyography guidance. Total

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Total score on Fahn-Tolosa-Marin scale at 6 weeks after the intervention session.Timepoint: 6 weeks

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactRoopa Rajan

All India Institute of Medical Sciences

drrooparajan@gmail.com9868398278

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 16, 2026