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

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

Sponsors

Lead Sponsor: All India Institute of Medical Sciences, New Delhi

Source All India Institute of Medical Sciences, New Delhi
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.

Overall Status Not yet recruiting
Start Date January 15, 2019
Completion Date August 30, 2020
Primary Completion Date August 1, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Efficacy of 4 weeks of mCIMT with sham/real rTMS Within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
Secondary Outcome
Measure Time Frame
To evaluate improvement in dissociated movements, grasp, weight bearing and protective extension in each group at the end of 4 weeks within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
To evaluate improvement in speed of upper limb movements in each group at the end of 4 weeks within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
To evaluate improvement in muscle strength in each group at the end of 4 weeks within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
To assess improvement in quality of life after the intervention in each group within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
To assess compliance to therapy in each group by Daily Compliance Log within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
To study for adverse events of TMS within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
To evaluate cortical excitability with TMS at baseline and the end of 4 weeks within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
• 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 within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
Enrollment 40
Condition
Intervention

Intervention Type: Device

Intervention Name: mCIMT with real rTMS

Description: Modified constraint induced movement therapy will be provided to all children according to predefined protocol. rTMS will be provided using figure of eight shaped coil and TMS stimulator ((Magventure Denmark, X100 with mapoption) over contra-lesional primary motor cortex over 10 sessions of 20 minutes each spread over 4 weeks. Each session will comprise priming ( 10 minutes of 6Hz rTMS at 90% of resting motor threshold, delivered in two trains per minute with 5 seconds per train and 25-seconds intervals between trains (a total of 600 priming pulses)). Priming will be followed immediately by additional 10 minutes of 1Hz rTMS at 90% of resting motor threshold without interruption (a total of 600 low-frequency pulses).

Arm Group Label: mCIMT with real rTMS

Intervention Type: Device

Intervention Name: mCIMT with sham rTMS

Description: Modified constraint induced movement therapy will be provided to all children according to predefined protocol. Sham rTMS will be given using a sham coil.

Arm Group Label: mCIMT with sham rTMS

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

Gender: All

Minimum Age: 5 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Sheffali Gulati, MD Principal Investigator All India Institute of Medical Sciences, New Delhi
Overall Contact

Last Name: Sheffali Gulati, MD

Phone: 09810386847

Email: [email protected]

Location
Facility: Contact: India Sheffali Gulati, MD 011-26594679 [email protected]
Location Countries

India

Verification Date

January 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: All India Institute of Medical Sciences, New Delhi

Investigator Full Name: Sheffali Gulati

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: mCIMT with real rTMS

Type: Experimental

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.

Label: mCIMT with sham rTMS

Type: Sham Comparator

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.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov