CTRI/2022/01/039806
Recruiting
Phase 3
Efficacy of repetitive transcranial magnetic stimulation in children and adolescents (5-18 years) with generalised dystonia :A randomised sham controlled trial
Child Neurology Division0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Child Neurology Division
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Children with age between 5 to 18 years of either sex.
- •2\.Presence of generalized dystonia
- •3\.On stable antidystonic pharmacotherapy and physiotherapy for atleast 3 months
- •4\. BFMDRS\-M score of 52 or more
Exclusion Criteria
- •Primary Exclusion Criteria
- •1\.Children diagnosed with progressive neurometabolic or neurodegenerative disorder on the basis of course of illness, neuroimaging and standard diagnostic evaluation.
- •2\.Children with unilateral dystonia
- •3\.Children with uncontrolled epilepsy defined as 4 or more seizures in last 6 months
- •4\.Children with metallic implants anywhere in the body.
- •5\.Children who underwent DBS/ pallidotomy.
- •6\.Parents refusing consent for enrolment in the study.
- •Secondary Exclusion Criteria (to be applied at the end of observation phase I)
- •1\.Change in antidystonia, antipsychotic or antiseizure medications during the observation period
- •2\.Occurrence of seizure during the observation period
Outcomes
Primary Outcomes
Not specified
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