Clinical trial NCT03792789: Evaluation of Repetitive Transcranial Magnetic Stimulation as an Adjunct to Modified Constraint Induced Movement Therapy in Improving Upper Limb Function in Children With Hemiparetic Cerebral Palsy Aged 5 - 18 Years
Official title: Evaluation of Repetitive Transcranial Magnetic Stimulation as an Adjunct to Modified Constraint Induced Movement Therapy in Improving Upper Limb Function in Children With Hemiparetic Cerebral Palsy Aged 5 - 18 Years - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiparetic Cerebral Palsy
Keywords: Transcranial Magnetic Stimulation (TMS)
modified Constraint Induced Movement Therapy (mCIMT)
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to evaluate efficacy of TMS as an adjunct to CIMT, assess its safety and tolerability and study cortical excitability with help of TMS which are both rehabilitative therapies for hemiplegic cerebral palsy.

Detailed description: Cerebral palsy is the most common motor disability of childhood and Hemiparetic cerebral palsy accounts for about one third of cases. Improving spasticity and upper limb function in these children can lead to better functional outcome and quality of life. TMS is an upcoming rehabilitative modality which has shown promising results in western studies. It has benefits of being non-invasive and has shown to have additive effect when used with CIMT which is standard of care in hemiparetic CP. However, randomized controlled clinical trials comparing it with CIMT alone in hemiparetic CP are very few, none from India so far. The dose, type and duration of TMS and its feasibility in resource limited set up needs to be investigated in children .Therefore, the investigators aim to evaluate efficacy of TMS as an adjunct to CIMT, assess its safety and tolerability and study cortical excitability with help of TMS.

Eligibility criteria: Inclusion Criteria:

* • Age 5 - 18 years

  * Hemiparetic Cerebral Palsy (perinatal brain injury)
  * Intelligence Quotient \>70 (Binet Kamat Test/Malin's Intelligence Scale for Children)
  * Modified Ashworth scoring 1-3 for affected limb
  * Can sit independently or with support (GMFCS stage : 1-4 and Manual Ability Classification System stage: 1-3)
  * Preserved vision and hearing (with or without correction)

Exclusion Criteria:

* • Uncontrolled epilepsy as defined by seizure frequency \>1/month for preceding 3 months

  * Severe concurrent illness or disease not associated with CP or unstable medical conditions like pneumonia
  * Genetic or syndromic associations
  * Children diagnosed with Autistic Spectrum Disorders
  * Modified Ashworth Scale Score more than 3 at shoulder/elbow/wrist
  * Contractures of affected limb
  * Severe movement disorder like dystonia, choreo-athetosis or ballismus interfering with purposeful limb movement
  * Any congenital brain malformation detected on conventional MRI brain
  * Recent surgery/cast/splint in affected limb
  * Botulinum toxin/phenol block in affected limb in past 6 months or planned to receive in study period
  * Those receiving tone modifying agents within two weeks before enrolment (Tizanidine, baclofen, benzodiazepines, dantrolene)
  * mCIMT received in last 6 months
  * Any contraindications for TMS - implanted electronic device and non-removable metallic objects near coil e.g. Pacemaker, cochlear implant

Primary outcomes:
measure: Efficacy of 4 weeks of mCIMT with sham/real rTMS
timeFrame: Within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
Secondary outcomes:
measure: To evaluate improvement in dissociated movements, grasp, weight bearing and protective extension in each group at the end of 4 weeks
timeFrame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
measure: To evaluate improvement in speed of upper limb movements in each group at the end of 4 weeks
timeFrame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
measure: To evaluate improvement in muscle strength in each group at the end of 4 weeks
timeFrame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
measure: To assess improvement in quality of life after the intervention in each group
timeFrame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
measure: To assess compliance to therapy in each group by Daily Compliance Log
timeFrame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
measure: To study for adverse events of TMS
timeFrame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
measure: To evaluate cortical excitability with TMS at baseline and the end of 4 weeks
timeFrame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
measure: • To evaluate sustenance of improvement by change in QUEST score at the end of 12 weeks, 8 weeks after stopping supervised treatment in both the groups
timeFrame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
Other outcomes:
Locations:
city: New Delhi
country: India
facility: India
Study officials:
affiliation: All India Institute of Medical Sciences
name: Sheffali Gulati, MD
role: PRINCIPAL_INVESTIGATOR
References: