NCT03792789

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

January 3, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

December 19, 2018

Last Update Submit

January 2, 2019

Conditions

Hemiparetic Cerebral Palsy

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Efficacy of 4 weeks of mCIMT with sham/real rTMS

    â—¦ 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

Secondary Outcomes (8)

  • 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

  • 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

    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

    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

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

  • +3 more secondary outcomes

Study Arms (2)

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.

Device: mCIMT with real rTMS

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.

Device: mCIMT with sham rTMS

Interventions

mCIMT with real rTMSDEVICE

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).

mCIMT with real rTMS
mCIMT with sham rTMSDEVICE

Modified constraint induced movement therapy will be provided to all children according to predefined protocol. Sham rTMS will be given using a sham coil.

mCIMT with sham rTMS

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

India

New Delhi, 110029, India

Location

Related Publications (1)

  • 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.

    PMID: 37170480DERIVED

Study Officials

  • Sheffali Gulati, MD

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheffali Gulati, MD

CONTACT

09810386847sheffaligulati@gmail.com

Juhi Gupta, MD

CONTACT

9999630637juhiguptadr@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 19, 2018

First Posted

January 3, 2019

Study Start

January 15, 2019

Primary Completion

August 1, 2020

Study Completion

August 30, 2020

Last Updated

January 3, 2019

Record last verified: 2019-01

Locations

IN(1)