Repetitive Transcranial Magnetic Stimulation on Motor Function and Meta-Plasticity in Cerebral Palsy: TMS-EEG Study

Part of paid clinical trials in Fort Worth, Texas.

Sponsor
Cook Children's Health Care System
Study ID
NCT07567053
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Cerebral Palsy
  • Typically Developing Children

Eligibility Criteria

Sex
ALL
Age
6 Years - 20 Years
Healthy Volunteers
Accepted

Interventions

  • MRI — DEVICE
    All participants will undergo an MRI scan prior to the intervention to acquire T1-weighted images. MRI data will be provided by the Cook Children's Radiology Department. MRI scans will be used for neuronavigation.
  • HD-EEG Recording — DEVICE
    High-density EEG (HD-EEG) is a safe and non-invasive brain imaging technique. It involves placing a cap with small sensors on the child's head to measure the brain's electrical activity. This technique does not send any energy into the brain. The investigators will use the HD-EEG to measure motor-evoked potentials (MEPs) and TMS-evoked potentials (TEPs).
  • rTMS — DEVICE
    rTMS is a safe, non-invasive way to map brain activity using gentle magnetic pulses. A small coil is placed near the head to stimulate nerve cells without any pain. This helps us understand how the brain controls movement.

Study Details

This project examines the use of repetitive transcranial magnetic stimulation (rTMS) as a therapeutic approach to improve motor function in children with cerebral palsy (CP). By applying 6-Hz primed low and high-frequency rTMS and measuring brain responses through TMS-EEG, the study aims to enhance neural plasticity and motor recovery. The goal is to promote faster rehabilitation and reduce long-term healthcare needs.

Key Dates

Start date
May 1, 2026
Status verified
May 2026
Primary completion
May 1, 2028
Completion
Jun 1, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Group 1
    CP participants in the experiment intervention group 1 will receive rTMS using a figure-of-eight-shaped coil and rTMS stimulator (Nexstim, Finland) targeting the contralesional primary motor cortex. The intervention will consist of 10 sessions, each lasting 20 minutes, spread over four weeks. Each session will begin with priming: 10 minutes of 6-Hz rTMS at 90% of the resting motor threshold, delivered in two trains per minute (5 seconds per train with 25-second intervals between trains), totaling 600 priming pulses. This will be followed immediately by 10 minutes of 1-Hz rTMS at 90% of the resting motor threshold, delivered continuously without interruption, totaling 600 low-frequency pulses.
  • Experimental: Intervention Group 2
    CP Participants in experiment intervention group 2 will receive rTMS targeting the ipsilesional primary motor cortex. The intervention will consist of 10 sessions, each lasting 20 minutes, spread over four weeks. Each session will start with priming: 10 minutes of 6-Hz rTMS at 90% of the resting motor threshold, delivered in two trains per minute (5 seconds per train with 25-second intervals between trains), totaling 600 priming pulses. This will be followed immediately by 10 minutes of 10 Hz rTMS at 90% of the resting motor threshold, delivered continuously without interruption, totaling 2000 high-frequency pulses.
  • Sham Comparator: Sham Group
    CP participants in the sham group will receive sham rTMS by positioning the coil perpendicular to the scalp without delivering active stimulation, targeting both the contralesional and ipsilesional primary motor cortex. The intervention will consist of 10 sessions, each lasting 20 minutes, spread over four weeks.
  • Active Comparator: Control Group
    Typically developed control group will complete a single baseline TMS-EEG session to measure TEPs. This involves high-density EEG recording during single-pulse TMS to assess cortical excitability. The session will last approximately 60-90 minutes.

Primary Outcome Measure

Change on TMS-evoked potentials (TEPs) [ Time Frame: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cook Children's HospitalFort WorthTexas76107
Dr. Christos Papadelis, PhD, PhD
[email protected]
682-305-3236
Behnam G Ghabel Damirchi, MSc (SUB_INVESTIGATOR)

Find similar trials in Fort Worth, TX

By research site
Cook Children's Hospital· Fort Worth, TX

Related Studies