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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: All India Institute of Medical Sciences · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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).
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.

Timeline

• Start date: 2019-01-15
• Primary completion: 2020-08-01
• Completion: 2020-08-30
• First posted: 2019-01-03
• Last updated: 2019-01-03

Locations

1 site across 1 country: India