Recruiting

TMS & CIMT

Sponsor:

University of Manitoba

Code:

NCT04902521

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 1 - 5

Healthy Volunteers: Not accepted

Interventions

Transcranial magnetic stimulation

Sham Transcranial Magnetic stimulation

Study Details

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.

Conditions

Cerebral Palsy

Study ID

NCT04902521

Start date

Jun 1, 2022

Status verified date

Jun, 2023

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 5

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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

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.

Primary outcome measure

  • Evaluation of Participant recruitment [ Time Frame: 5 Months ]
  • Evaluation of Participant retention during trial [ Time Frame: 5 Months ]
  • Incidence of Treatment-Emergent Adverse Events as assessed by Parental Reports [ Time Frame: 5 Months ]
  • Effectiveness of the transcrainial magnetic stimulation blinding process on patients and therapist [ Time Frame: 5 months ]
  • Evaluation of treatment intervention by parental guardians [ Time Frame: 3 months ]
  • Estimation of intervention costs [ Time Frame: 5 months ]

Central Contacts and Locations

Central contacts

Florencia Ricci, MD, PhD

2042586549fricci@hsc.mb.ca

Locations

SSCY/RCC

Recruiting

Winnipeg, Manitoba, Canada, R3E3G1

Contacts

Florencia Ricci, MD, PhD

fricci@hsc.ca

More Information

Sponsor

University of Manitoba

Last update posted

Jun 9, 2023

Last verified

Jun, 2023

Keywords

  • cerebral palsy
  • constrain induced muscle therapy
  • Transcranial magnetic stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2023-06-09.