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

All India Institute Of Medical Science (AIIMS)

Status: Unknown

Conditions: Hemiparetic Cerebral Palsy

Treatments: Device: mCIMT with real rTMS; Device: mCIMT with sham rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03792789

IECPG/574/11/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

mCIMT with real rTMS

Experimental group

Description:

Modified Constraint Induced Movement Therapy (mCIMT) with real Repetitive Transcranial Magnetic Stimulation (rTMS). 10 sessions of mCIMT will be administered using physical rehabilitation protocol along with real rTMS over contralateral primary motor cortex.

Treatment:

Device: mCIMT with real rTMS

mCIMT with sham rTMS

Sham Comparator group

Description:

Modified Constraint Induced Movement Therapy with sham Repetitive Transcranial Magnetic Stimulation (using sham coil). 10 sessions of mCIMT will be administered using physical rehabilitation protocol along with sham rTMS over contralateral primary motor cortex using sham coil which simulated sound and touch of real coil but has no electro-magnetic waves.

Treatment:

Device: mCIMT with sham rTMS