Health Condition 1: G249- Dystonia, unspecified
Conditions
Interventions
Intervention1: Repetitive low frequency (1 Hz) transcranial magnetic stimulation on Premotor cortex: Repetitive transcranial magnetic stimulation with low frequency and high intensity stimulus will be
Sponsors
Child Neurology Division
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate proportion of children with generalized dystonia showing reduction in Burke Fahn Marsden Dystonia Rating Scale- Motor (BFMDRS-M) score of =20 % from baseline with adjunct r TMS therapy at 12 ± 1week follow up.Timepoint: Baseline,12 ± 1week | — |
Secondary
| Measure | Time frame |
|---|---|
| To analyse the mean change in IQ/SQ and behaviour from baseline, at 12 ± 1 weeks of rTMS therapy in children aged 5 -18 years with generalised dystonia at at 12 ± 1weeksTimepoint: Baseline,12 ± 1week;To analyze mean reduction in Burke Fahn Marsden Dystonia Rating Scale- Motor (BFMDRS-M) score with adjunct rTMS therapy in children aged 5 -18 years with generalized dystonia at 12 ± 1 week follow up. Timepoint: Baseline,12 ± 1weeks;To analyze the change in brain glucose metabolism as assessed by pre (baseline) and post rTMS therapy (12 ±1week) 18F-FDG positron emission tomography (PET) scan findings in at 12 ± 1weeks in children aged 5 -18 years with generalized dystonia in atleast 10 patients.Timepoint: Baseline,12 ± 1week;To analyze the changes in blood oxygen level dependent (BOLD) signals as assessed by pre(baseline) and post rTMS therapy changes in functional MRI findings at 12 ± 1weeks in children aged 5 -18 years with generalized dystonia in atleast 10 patients.Timepoint: Baseline,12 ± 1week;To analyze the mean change in functional ability as assessed using disability score of Burke Fahn Marsden Dystonia Rating Scale (BFMDRS-D) with adjunct rTMS therapy in children aged 5 -18 years with generalized dystonia at 12 ± 1 week follow up.Timepoint: Baseline, 12 ± 1 week;To analyze the mean change in Non-Communicating Children’s Pain Checklist-Revised (NCCPC-R) score with adjunct rTMS therapy in children aged 5 -18 years with generalized dystonia at 12 ± 1 week follow upTimepoint: Baseline,12 ± 1 week;To assess change in motor cortex excitability as assessed by single pulse TMS parameters (RMT and SICI) between pre (baseline) and post r TMS therapy (12 ±1week) in children aged 5 -18 years with generalized dystonia. Timepoint: Baseline,12 ± 1week;To do subgroup analysis to analyze the mean change in BFMDRS score with adjunct rTMS therapy in children aged 5 -18 years with Primary dystonia at 12 ± 1 week follow upTimepoint: Baseline,12 ± 1week;To evaluate the effect o | — |
Countries
India
Contacts
Public ContactDr Sakshi Ojha
AIIMS NEW DELHI
Outcome results
None listed