Hemiparetic Cerebral PalsyNCT03792789
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 study testing mCIMT with real rTMS in people with Hemiparetic Cerebral Palsy, run by All India Institute of Medical Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Hemiparetic Cerebral Palsy
- What is being tested?
- mCIMT with real rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jan 2019to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- • 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)
Who cannot join
- • 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
India
New Delhi, 110029
Sheffali Gulati, MD, 011-26594679, sheffaligulati@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Hemiparetic Cerebral Palsy
- Being tested
- mCIMT with real rTMS, mCIMT with sham rTMS
- Keywords
- Transcranial Magnetic Stimulation (TMS), modified Constraint Induced Movement Therapy (mCIMT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: mCIMT with sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
To evaluate improvement in dissociated movements, grasp, weight bearing and protective extension in each group at the end of 4 weeks
Measured: 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
To evaluate improvement in speed of upper limb movements in each group at the end of 4 weeks
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start15 Jan 2019 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemiparetic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheffali Gulati, All India Institute of Medical Sciences
- Investigators
- Sheffali Gulati, MD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792789
- Sponsor's protocol ID
- IECPG/574/11/2018
- Status last verified
- Jan 2019
- First submitted
- 19 Dec 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37170480
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03792789
- Acronym / sponsor ID
- IECPG/574/11/2018
- Conditions
- Hemiparetic Cerebral Palsy
- Keywords
- Transcranial Magnetic Stimulation (TMS), modified Constraint Induced Movement Therapy (mCIMT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 15 Jan 2019 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mCIMT with real rTMS | Experimental | Device: mCIMT with real rTMSModified 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. |
| mCIMT with sham rTMS | Sham comparator | Device: mCIMT with sham rTMSModified 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- • Age 5 - 18 years
Key exclusion criteria (13 listed)
- • Uncontrolled epilepsy as defined by seizure frequency >1/month for preceding 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mCIMT with real rTMSModified 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). | Device | mCIMT with real rTMS |
| mCIMT with sham rTMSModified constraint induced movement therapy will be provided to all children according to predefined protocol. Sham rTMS will be given using a sham coil. | Device | mCIMT with sham rTMS |
Primary outcome
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
8 secondary outcomes
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 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 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 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 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 study for adverse events of TMS
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
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
Time frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Derived from this study: PubMed 37170480Gupta 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.
- Individual participant dataSharing planned: Undecided
Related trials for Hemiparetic Cerebral Palsy
Not yet recruiting
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy
Active, not recruiting
Robot-Assisted Mirror Therapy in the Rehabilitation of Hemiparetic Cerebral Palsy
Cerebral Palsy (CP), Hemiparetic Cerebral Palsy
Not yet recruiting
Mirror Therapy in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy, Mirror Hands
Not yet recruiting
Effect of Reciprocal Electrical Stimulation on Balance and Quality of Life in Hemiparetic CP
Hemiparetic Cerebral Palsy
Active, not recruiting
Effect of Blood Flow Restriction Training Exercises on Hand Grip Strength in Hemiparetic Cerebral Palsied Children
Cerebral Palsy Spastic Hemiplegic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheffali Gulati, MD principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mCIMT with real rTMS in people with Hemiparetic Cerebral Palsy, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheffali Gulati, MD (09810386847, sheffaligulati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03792789, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.