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

NCT ID: NCT03792789

Last Updated: 2019-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2020-08-30

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.

Conditions

Hemiparetic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

mCIMT with real rTMS

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.

Group Type: EXPERIMENTAL

mCIMT with real rTMS

Intervention Type: DEVICE

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).

mCIMT with sham rTMS

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.

Group Type: SHAM_COMPARATOR

mCIMT with sham rTMS

Intervention Type: DEVICE

Modified constraint induced movement therapy will be provided to all children according to predefined protocol.

Sham rTMS will be given using a sham coil.

Interventions

mCIMT with real rTMS

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).

Intervention Type: DEVICE

mCIMT with sham rTMS

Modified constraint induced movement therapy will be provided to all children according to predefined protocol.

Sham rTMS will be given using a sham coil.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Sheffali Gulati

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheffali Gulati, MD

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Locations

India

New Delhi, , India

Countries

India

Central Contacts

Sheffali Gulati, MD

Role: CONTACT

sheffaligulati@gmail.com

09810386847

Juhi Gupta, MD

Role: CONTACT

juhiguptadr@gmail.com

9999630637

Facility Contacts

Sheffali Gulati, MD

Role: primary

sheffaligulati@gmail.com

011-26594679

References

Gupta J, Gulati S, Singh UP, Kumar A, Jauhari P, Chakrabarty B, Pandey RM, Bhatia R, Jain S, Srivastava A. Brain Stimulation and Constraint Induced Movement Therapy in Children With Unilateral Cerebral Palsy: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2023 May;37(5):266-276. doi: 10.1177/15459683231174222. Epub 2023 May 11.

Reference Type: DERIVED

PMID: 37170480 (View on PubMed)

Other Identifiers

IECPG/574/11/2018

Identifier Type: -

Identifier Source: org_study_id