Use of Transcranial Magnetic Stimulation and Constraint Induced Movement Therapy in Pediatric Unilateral Cerebral Palsy

June 8, 2023 updated by: M. Florencia Ricci, University of Manitoba

Concurrent Use of Transcranial Magnetic Stimulation and Constraint Induced Movement Therapy in Children With Unilateral Cerebral Palsy: A Feasibility Study

Cerebral Palsy (CP) is the most common cause of childhood physical disability. Early CP diagnosis and intervention are crucial to improving outcomes in these patients. Constraint-induced movement therapy (CIMT) has become a standard therapeutic intervention for children with unilateral CP. CIMT utilizes restraining of the unaffected upper limb to stimulate the use of the paretic upper limb enhancing neuroplasticity in the affected cerebral hemisphere.

Transcranial magnetic stimulation (TMS) is a safe non-invasive technique that stimulates the brain using repetitive magnetic pulses to enhance neuroplasticity. TMS has been shown to improve symptoms of children with neurodevelopmental disorders such as CP. It is predicted that a combined therapy that uses CIMT and TMS is could improve mobility in children with unilateral CP.

To determine if combined therapy is beneficial to children with CP and if use of this therapy is feasible for families, the investigators would like to conducted a feasibility trial. In this trial the investigators will enrol 10 children who have unilateral CP, the participants will either receive:

  1. CIMT and TMS or;
  2. CIMT and fake TMS, fake TMS consist of a child sitting near the TMS machine but not receiving any TMS.

The aim of this project is to determine if it is feasible to conduct a large randomized control trial to compare the effects of combined CIMT and TMS versus CIMT and fake TMS.The investigators also hope that by conducting this trial they can identify any benefits that the addition of TMS may have in children with CP.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cerebral Palsy (CP) is the most common cause of childhood physical disability. Early CP diagnosis and intervention are crucial in optimizing neuroplasticity and improving outcomes. One such intervention is constraint-induced movement therapy (CIMT), a therapeutic approach used in children with unilateral CP. CIMT utilizes restraining of the unaffected upper limb to stimulate the use of the paretic upper limb enhancing neuroplasticity in the affected cerebral hemisphere.CIMT is more effective than other rehabilitation approaches in improving upper limb function and has become a standard therapeutic intervention for children with unilateral CP.

Repetitive transcranial magnetic stimulation (TMS) is a safe non-invasive technique that stimulates the brain using repetitive magnetic pulses to enhance neuroplasticity. TMS has been shown to produce lasting modulation of cortical activity and improve clinical symptoms of children with neurodevelopmental disorders including CP.

A recent Canadian study, the PLASTIC Champs trial, demonstrated that combining TMS and CIMT for children with unilateral CP secondary to perinatal stroke produced greater improvements in upper limb function when compared to CIMT or TMS alone. Though promising, there are three features of the Plastic Champs trial that could limit its generalizability. First, it took place in a very special, intensive setting of daily CIMT/TMS during a 14-day camp. Second is the single cause of CP studied. And finally, it included only school-age children. To date, no research study has evaluated if findings from the PLASTIC Champs trial could be replicated when utilizing the combination of CIMT and TMS in a regular clinical environment, and among younger children.

A feasibility study is an appropriate first step towards our plan of performing a definitive RCT on the topic.

In this trial the investigators will enrol 10 children who have unilateral CP, they will either receive:

  1. CIMT and TMS or;
  2. CIMT and fake TMS, fake TMS consist of a child sitting near the TMS machine but not receiving any TMS.

The Investigators seek to evaluate whether, in younger children, the addition of TMS to the more commonly used, intermittent outpatient regimen of CIMT improves the motor outcomes of the upper limb.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Florencia Ricci, MD, PhD
  • Phone Number: 2042586549
  • Email: fricci@hsc.mb.ca

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E3G1
        • Recruiting
        • SSCY/RCC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosis of unilateral spastic CP
  • assessed as Gross Motor Function Classification System level I to III
  • assessed as Manual Ability Classification System level II to level IV

Exclusion Criteria:

  • have received CIMT in the last 6 month
  • do not have neuroimaging studies to confirm clinical diagnosis of CP
  • severe impairments limiting their ability to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial magnetic stimulation with constraint induced movement therapy
CIMT/TMS: Five participants will receive a one-hour weekly occupational therapy session of CIMT with 2-hours of daily home program for a total of 6 weeks; immediately prior to initiation of each CIMT session, participants will receive 20 minutes of TMS 1HZ.
Device: Transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (TMS) is a safe non-invasive technique that stimulates the brain using repetitive magnetic pulses to enhance neuroplasticity. TMS has been shown to produce lasting modulation of cortical activity and improve clinical symptoms of children with neurodevelopmental disorders including CP
Other Names:
  • TMS
Sham Comparator: constraint induced movement therapy Sham transcrianial magnetic stimulation
(CIMT/sham TMS): Five participants will receive a one-hour weekly session of CIMT with 2-hours daily of home program for a total of 6 weeks; immediately prior to initiation of each CIMT session, participants will receive 20 minutes of sham TMS 1HZ.
Device: Sham Transcranial Magnetic stimulation
Sham Transcranial Magnetic stimulation will be given to the control group. During the Sham procedure patients will sit near the TMS but will not receive any magnetic pulses.
Other Names:
  • Sham TMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Participant recruitment
Time Frame: 5 Months
Participant recruitment: We will assess number of eligible children, reasons for ineligibility and non-participation.
5 Months
Evaluation of Participant retention during trial
Time Frame: 5 Months
We will assess and report the number of missing variables and number of patients with incomplete outcome measures.
5 Months
Incidence of Treatment-Emergent Adverse Events as assessed by Parental Reports
Time Frame: 5 Months
We will ask parents to report weekly on the presence of previously reported side effects including headaches, anxiety, dizziness, tingling, mood changes, difficulties with concentration, abnormal muscle contractions, nausea, stomach ache, fatigue and decreased hand function of either hand. For completeness we will also ask about presence of seizures (new onset or increase in existing seizures), although this side effect was not seen in previous safety studies. We will also assess number of times (and reasons) TMS session ended before the stipulated time and number of minutes lost.
5 Months
Effectiveness of the transcrainial magnetic stimulation blinding process on patients and therapist
Time Frame: 5 months
TMS sham process and blinding of patients and therapist: At the end of the study we will ask parents/ occupational therapist assessing outcomes to report on possible group allocation of participant (could they identify if the participant received TMS or sham TMS?)
5 months
Evaluation of treatment intervention by parental guardians
Time Frame: 3 months

Acceptability of treatment: Based on Gillick's work, at the end of the intervention (6 weeks) and 3 months post completion, we will ask parents to rate on a scale of 1 to 10 their "satisfaction with the intervention, willingness to repeat the study, and likelihood of recommending the study to others." .

- Participant research engagement: At the end of the study we will ask parents to rate their willingness to participate as a research-collaborator in a future large RCT study.
3 months
Estimation of intervention costs
Time Frame: 5 months
This study will provide information needed to develop a budget for the future application.
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of mobility using Small Kids-AHA
Time Frame: 5 months
We will assess differences between pre-to post intervention using the Small Kids- AHA scores among those undergoing CIMT+TMS vs. CIMT/sham TMS. Small Kids-AHA is a measure of bimanual performance and is rated on a scale or 0-100 (100 being high functionality).
5 months
Assessment of mobility using the Canadian Occupational Performance Measure (COPM)
Time Frame: 5 months
We will assess differences between pre-to post intervention using the Canadian Occupational Performance Measure (COPM) scores among those undergoing CIMT+TMS vs. CIMT/sham TMS. Canadian Occupational Performance Measure is used to asses daily functioning and is scored on a 10 point scale (10 being high functionality).
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

May 20, 2021

First Posted (Actual)

May 26, 2021

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS24766(B2021:023)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy

Clinical Trials on Transcranial magnetic stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe