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 - Clinical Trial for Hemiparetic Cerebral Palsy | NCT03792789

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

mCIMT with real rTMS

mCIMT with sham rTMS

About this trial

This is an interventional treatment trial for Hemiparetic Cerebral Palsy focused on measuring Transcranial Magnetic Stimulation (TMS), modified Constraint Induced Movement Therapy (mCIMT)

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

India

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

mCIMT with real rTMS

mCIMT with sham rTMS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 speed of upper limb movements in each group at the end of 4 weeks

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

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

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

To study for adverse events of TMS

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

• 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

Full Information

NCT ID

NCT03792789

First Posted

December 19, 2018

Last Updated

January 2, 2019

Sponsor

All India Institute of Medical Sciences, New Delhi

1. Study Identification

Unique Protocol Identification Number

NCT03792789

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 15, 2019 (Anticipated)

Primary Completion Date

August 1, 2020 (Anticipated)

Study Completion Date

August 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

All India Institute of Medical Sciences, New Delhi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemiparetic Cerebral Palsy

Keywords

Transcranial Magnetic Stimulation (TMS), modified Constraint Induced Movement Therapy (mCIMT)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mCIMT with real rTMS

Arm Type

Experimental

Arm Description

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.

Arm Title

mCIMT with sham rTMS

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

mCIMT with real rTMS

Intervention Description

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

Intervention Name(s)

mCIMT with sham rTMS

Intervention Description

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 Measure Information:

Title

Efficacy of 4 weeks of mCIMT with sham/real rTMS

Description

◦ 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

Time Frame

Within 1 week of end of 4 weeks of mCIMT with sham/real rTMS

Secondary Outcome Measure Information:

Title

To evaluate improvement in dissociated movements, grasp, weight bearing and protective extension in each group at the end of 4 weeks

Description

To evaluate improvement in dissociated movements, grasp, weight bearing and protective extension in each group at the end of 4 weeks

Time Frame