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

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sham Transcranial Magnetic stimulation
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, constrain induced muscle therapy, Transcranial magnetic stimulation

Eligibility Criteria

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

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

Sites / Locations

  • SSCY/RCCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial magnetic stimulation with constraint induced movement therapy

constraint induced movement therapy Sham transcrianial magnetic stimulation

Arm Description

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.

(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.

Outcomes

Primary Outcome Measures

Evaluation of Participant recruitment
Participant recruitment: We will assess number of eligible children, reasons for ineligibility and non-participation.
Evaluation of Participant retention during trial
We will assess and report the number of missing variables and number of patients with incomplete outcome measures.
Incidence of Treatment-Emergent Adverse Events as assessed by Parental Reports
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.
Effectiveness of the transcrainial magnetic stimulation blinding process on patients and therapist
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?)
Evaluation of treatment intervention by parental guardians
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.
Estimation of intervention costs
This study will provide information needed to develop a budget for the future application.

Secondary Outcome Measures

Assessment of mobility using Small Kids-AHA
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).
Assessment of mobility using the Canadian Occupational Performance Measure (COPM)
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).

Full Information

First Posted
April 22, 2021
Last Updated
June 8, 2023
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT04902521
Brief Title
Use of Transcranial Magnetic Stimulation and Constraint Induced Movement Therapy in Pediatric Unilateral Cerebral Palsy
Official Title
Concurrent Use of Transcranial Magnetic Stimulation and Constraint Induced Movement Therapy in Children With Unilateral Cerebral Palsy: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

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

5. Study Description

Brief Summary
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: CIMT and TMS or; 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.
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: CIMT and TMS or; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, constrain induced muscle therapy, Transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial magnetic stimulation with constraint induced movement therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
constraint induced movement therapy Sham transcrianial magnetic stimulation
Arm Type
Sham Comparator
Arm Description
(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.
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Other Intervention Name(s)
TMS
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Magnetic stimulation
Other Intervention Name(s)
Sham TMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of Participant recruitment
Description
Participant recruitment: We will assess number of eligible children, reasons for ineligibility and non-participation.
Time Frame
5 Months
Title
Evaluation of Participant retention during trial
Description
We will assess and report the number of missing variables and number of patients with incomplete outcome measures.
Time Frame
5 Months
Title
Incidence of Treatment-Emergent Adverse Events as assessed by Parental Reports
Description
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.
Time Frame
5 Months
Title
Effectiveness of the transcrainial magnetic stimulation blinding process on patients and therapist
Description
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?)
Time Frame
5 months
Title
Evaluation of treatment intervention by parental guardians
Description
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.
Time Frame
3 months
Title
Estimation of intervention costs
Description
This study will provide information needed to develop a budget for the future application.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Assessment of mobility using Small Kids-AHA
Description
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).
Time Frame
5 months
Title
Assessment of mobility using the Canadian Occupational Performance Measure (COPM)
Description
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).
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florencia Ricci, MD, PhD
Phone
2042586549
Email
fricci@hsc.mb.ca
Facility Information:
Facility Name
SSCY/RCC
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E3G1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florencia Ricci, MD, PhD
Email
fricci@hsc.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17370477
Citation
Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. Erratum In: Dev Med Child Neurol. 2007 Jun;49(6):480.
Results Reference
background
PubMed Identifier
28715518
Citation
Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689. Erratum In: JAMA Pediatr. 2017 Sep 1;171(9):919.
Results Reference
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PubMed Identifier
21950396
Citation
Gordon AM. To constrain or not to constrain, and other stories of intensive upper extremity training for children with unilateral cerebral palsy. Dev Med Child Neurol. 2011 Sep;53 Suppl 4:56-61. doi: 10.1111/j.1469-8749.2011.04066.x.
Results Reference
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PubMed Identifier
24309263
Citation
Uswatte G, Taub E. Constraint-induced movement therapy: a method for harnessing neuroplasticity to treat motor disorders. Prog Brain Res. 2013;207:379-401. doi: 10.1016/B978-0-444-63327-9.00015-1.
Results Reference
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PubMed Identifier
25125440
Citation
Chen YP, Pope S, Tyler D, Warren GL. Effectiveness of constraint-induced movement therapy on upper-extremity function in children with cerebral palsy: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2014 Oct;28(10):939-53. doi: 10.1177/0269215514544982. Epub 2014 Aug 14.
Results Reference
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PubMed Identifier
24366991
Citation
Sakzewski L, Ziviani J, Boyd RN. Efficacy of upper limb therapies for unilateral cerebral palsy: a meta-analysis. Pediatrics. 2014 Jan;133(1):e175-204. doi: 10.1542/peds.2013-0675. Epub 2013 Dec 23.
Results Reference
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PubMed Identifier
25236758
Citation
Eliasson AC, Holmefur M. The influence of early modified constraint-induced movement therapy training on the longitudinal development of hand function in children with unilateral cerebral palsy. Dev Med Child Neurol. 2015 Jan;57(1):89-94. doi: 10.1111/dmcn.12589. Epub 2014 Sep 19.
Results Reference
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PubMed Identifier
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Citation
Masuda F, Nakajima S, Miyazaki T, Tarumi R, Ogyu K, Wada M, Tsugawa S, Croarkin PE, Mimura M, Noda Y. Clinical effectiveness of repetitive transcranial magnetic stimulation treatment in children and adolescents with neurodevelopmental disorders: A systematic review. Autism. 2019 Oct;23(7):1614-1629. doi: 10.1177/1362361318822502. Epub 2019 Jan 20.
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Citation
Kirton A, Andersen J, Herrero M, Nettel-Aguirre A, Carsolio L, Damji O, Keess J, Mineyko A, Hodge J, Hill MD. Brain stimulation and constraint for perinatal stroke hemiparesis: The PLASTIC CHAMPS Trial. Neurology. 2016 May 3;86(18):1659-67. doi: 10.1212/WNL.0000000000002646. Epub 2016 Mar 30.
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Use of Transcranial Magnetic Stimulation and Constraint Induced Movement Therapy in Pediatric Unilateral Cerebral Palsy

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