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

NCT04902521 | Unknown FDA Device

• 1 other identifier: HS24766(B2021:023)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Cerebral Palsy

Keywords

cerebral palsy; constrain induced muscle therapy; Transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (6)

• Evaluation of Participant recruitment

  Participant recruitment: We will assess number of eligible children, reasons for ineligibility and non-participation.

  5 Months

• Evaluation of Participant retention during trial

  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

  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

  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

  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

  This study will provide information needed to develop a budget for the future application.

  5 months

Secondary Outcomes (2)

• Assessment of mobility using Small Kids-AHA

  5 months

• Assessment of mobility using the Canadian Occupational Performance Measure (COPM)

  5 months

Study Arms (2)

Transcranial magnetic stimulation with constraint induced movement therapy

EXPERIMENTAL

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

constraint induced movement therapy Sham transcrianial magnetic stimulation

SHAM COMPARATOR

(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

Interventions

Transcranial magnetic stimulation DEVICE

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

Also known as: TMS

Transcranial magnetic stimulation with constraint induced movement therapy

Sham Transcranial Magnetic stimulation DEVICE

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.

Also known as: Sham TMS

constraint induced movement therapy Sham transcrianial magnetic stimulation

Eligibility Criteria

• Age: 18 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

SSCY/RCC

Winnipeg, Manitoba, R3E3G1, Canada

RECRUITING

Related Publications (9)

• 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.

  PMID: 17370477 BACKGROUND

• 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.

  PMID: 28715518 BACKGROUND

• 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.

  PMID: 21950396 BACKGROUND

• 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.

  PMID: 24309263 BACKGROUND

• 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.

  PMID: 25125440 BACKGROUND

• 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.

  PMID: 24366991 BACKGROUND

• 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.

  PMID: 25236758 BACKGROUND

• 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.

  PMID: 30663323 BACKGROUND

• 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.

  PMID: 27029628 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Florencia Ricci, MD, PhD

CONTACT

2042586549; fricci@hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Developmental Pediatrician

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 26, 2021
• Study Start: June 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-06

Locations

CA (1)