- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sheffali Gulati, MD
- Phone Number: 09810386847
- Email: sheffaligulati@gmail.com
Study Contact Backup
- Name: Juhi Gupta, MD
- Phone Number: 9999630637
- Email: juhiguptadr@gmail.com
Study Locations
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New Delhi, India, 110029
- India
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Contact:
- Sheffali Gulati, MD
- Phone Number: 011-26594679
- Email: sheffaligulati@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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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). |
Sham Comparator: 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.
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Modified constraint induced movement therapy will be provided to all children according to predefined protocol. Sham rTMS will be given using a sham coil. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of 4 weeks of mCIMT with sham/real rTMS
Time Frame: Within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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◦ 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
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Within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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Secondary Outcome Measures
Outcome Measure |
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
Time Frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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To evaluate improvement in dissociated movements, grasp, weight bearing and protective extension in each group at the end of 4 weeks
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within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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To evaluate improvement in speed of upper limb movements in each group at the end of 4 weeks
Time Frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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To evaluate improvement in speed of upper limb movements in each group at the end of 4 weeks
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within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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To evaluate improvement in muscle strength in each group at the end of 4 weeks
Time Frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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To evaluate improvement in muscle strength in each group at the end of 4 weeks
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within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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To assess improvement in quality of life after the intervention in each group
Time Frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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To assess improvement in quality of life after the intervention in each group
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within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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To assess compliance to therapy in each group by Daily Compliance Log
Time Frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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To assess compliance to therapy in each group by Daily Compliance Log
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within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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To study for adverse events of TMS
Time Frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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To study for adverse events of TMS
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within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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To evaluate cortical excitability with TMS at baseline and the end of 4 weeks
Time Frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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To evaluate cortical excitability with TMS at baseline and the end of 4 weeks
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within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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• 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
Time Frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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• 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
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within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
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Collaborators and Investigators
Investigators
- Principal Investigator: Sheffali Gulati, MD, All India Institute of Medical Sciences, New Delhi
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IECPG/574/11/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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