CTRI/2022/01/039806RecruitingPhase 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 enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
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
- •3.Repeat BFMDRS-M score after 4 week observation <52
Investigators
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