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Trial record 37 of 67 for:    strength | ( Map: India )

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

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ClinicalTrials.gov Identifier: NCT03792789
Recruitment Status : Not yet recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Sheffali Gulati, 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.

Condition or disease Intervention/treatment Phase
Hemiparetic Cerebral Palsy Device: mCIMT with real rTMS Device: mCIMT with sham rTMS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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).


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.
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.





Primary Outcome Measures :
  1. 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 ]
    ◦ 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


Secondary Outcome Measures :
  1. 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 ]
    To evaluate improvement in dissociated movements, grasp, weight bearing and protective extension in each group at the end of 4 weeks

  2. 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 ]
    To evaluate improvement in speed of upper limb movements in each group at the end of 4 weeks

  3. 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 ]
    To evaluate improvement in muscle strength in each group at the end of 4 weeks

  4. 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 ]
    To assess improvement in quality of life after the intervention in each group

  5. 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 ]
    To assess compliance to therapy in each group by Daily Compliance Log

  6. To study for adverse events of TMS [ Time Frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS ]
    To study for adverse events of TMS

  7. 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 ]
    To evaluate cortical excitability with TMS at baseline and the end of 4 weeks

  8. • 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 ]
    • 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



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792789


Contacts
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Contact: Sheffali Gulati, MD 09810386847 sheffaligulati@gmail.com
Contact: Juhi Gupta, MD 9999630637 juhiguptadr@gmail.com

Locations
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India
India Not yet recruiting
New Delhi, India, 110029
Contact: Sheffali Gulati, MD    011-26594679    sheffaligulati@gmail.com   
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
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Principal Investigator: Sheffali Gulati, MD All India Institute of Medical Sciences, New Delhi

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Responsible Party: Sheffali Gulati, Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT03792789     History of Changes
Other Study ID Numbers: IECPG/574/11/2018
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sheffali Gulati, All India Institute of Medical Sciences, New Delhi:
Transcranial Magnetic Stimulation (TMS)
modified Constraint Induced Movement Therapy (mCIMT)
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases