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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mCIMT with real rTMS | Experimental | 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. |
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| mCIMT with sham rTMS | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mCIMT with real rTMS | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of 4 weeks of mCIMT with sham/real rTMS | ◦ To evaluate the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as an adjunct to modified Constraint Induced Movement Therapy (mCIMT) for 4 weeks in improving the Upper Limb Function as per increase in total QUEST score by 5 in 5-18 years old children with Hemiparetic Cerebral Palsy | Within 1 week of end of 4 weeks of mCIMT with sham/real rTMS |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate improvement in dissociated movements, grasp, weight bearing and protective extension in each group at the end of 4 weeks | 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 |
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Inclusion Criteria:
• Age 5 - 18 years
Exclusion Criteria:
• Uncontrolled epilepsy as defined by seizure frequency >1/month for preceding 3 months
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheffali Gulati, MD | Contact | 09810386847 | sheffaligulati@gmail.com | |
| Juhi Gupta, MD | Contact | 9999630637 | juhiguptadr@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sheffali Gulati, MD | All India Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| India | New Delhi | 110029 | India |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37170480 | Derived | 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. |
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| mCIMT with sham rTMS | 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. |
|
| To evaluate improvement in speed of upper limb movements in each group at the end of 4 weeks |
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 | 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 | 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 | 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 | 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 | 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 | • 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 |