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

NCT ID: NCT04902521

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-12-31

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. 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.

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

Sham Transcranial Magnetic stimulation

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

TMS; Sham TMS

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

M. Florencia Ricci

Principle Investigator, Developmental Pediatrician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

SSCY/RCC

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Florencia Ricci, MD, PhD

Role: CONTACT

fricci@hsc.mb.ca

2042586549

Facility Contacts

Florencia Ricci, MD, PhD

Role: primary

fricci@hsc.ca

References

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Reference Type: BACKGROUND

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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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Other Identifiers

HS24766(B2021:023)

Identifier Type: -

Identifier Source: org_study_id