Recruiting

rTMS

Sponsor:

Cook Children's Health Care System

Code:

NCT07567053

Conditions

Cerebral Palsy

Typically Developing Children

Eligibility Criteria

Sex: All

Age: 6 - 20

Healthy Volunteers: Accepted

Interventions

MRI

HD-EEG Recording

rTMS

Study Details

Brief summary:

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.

Conditions

Cerebral Palsy

Typically Developing Children

Study ID

NCT07567053

Start date

May 27, 2026

Status verified date

Oct, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 20

Healthy Volunteers: Accepted

Inclusion Criteria (CP):

  • Aged 6 - 20 years,
  • A confirmed diagnosis of CP by a specialized professional (pediatric neurologist, PM\&R physician, neonatal developmental specialist, or neonatologist) is a prerequisite for participation,
  • Classified as high functioning (Level I, II, or III) according to the Gross Motor Function Classification System (GMFCS),
  • Age-appropriate ability to understand and comply with study procedure throughout the entire duration of the study,
  • Preserved vision and hearing (with or without correction).

Inclusion Criteria (TD):

  • Aged 6 - 20 years
  • Age-appropriate ability to understand and comply with study procedure throughout the entire duration of the study,
  • Preserved vision and hearing (with or without correction).

Exclusion Criteria (CP):

  • Syndromic or genetic brain-related associations,
  • History of major trauma or brain surgery,
  • Inability to remain still,
  • History of Epilepsy,
  • Severe coexisting sickness or illness unrelated to CP or unstable medical conditions such as pneumonia,
  • Modified Ashworth Scale: Shoulder, elbow, and wrist scores more than 3,
  • Limb contractures caused by any other injury except CP,
  • Severe movement disorders that prevent intentional limb movements, such as choreoathetosis, or ballismus,
  • Contraindications for rTMS include non-removable metallic objects close to a coil and implanted electronic devices, such as cochlear implants and pacemakers.

Exclusion Criteria (TD):

  • Syndromic or genetic brain-related associations,
  • History of major trauma or brain surgery,
  • Inability to remain still,
  • History of Epilepsy,
  • Severe coexisting sickness or illness unrelated to CP or unstable medical conditions such as pneumonia,
  • Limb contractures caused by injury,
  • Severe movement disorders that prevent intentional limb movements, such as choreoathetosis, or ballismus,
  • Contraindications for rTMS include non-removable metallic objects close to a coil and implanted electronic devices, such as cochlear implants and pacemakers.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

MRI

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

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

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.

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 and Locations

Central contacts

Christos Papadelis, PhD

682-305-3236Christos.Papadelis@cookchildrens.org

Behnam Ghabel Damirchi, MSc

682-367-3956behnam.ghabeldamirchi@cookchildrens.org

Locations

Cook Children's Hospital

Recruiting

Fort Worth, Texas, United States, 76107

Contacts

Christos Dr. Papadelis, PhD, PhD

682-305-3236Christos.Papadelis@cookchilrens.org

More Information

Sponsor

Cook Children's Health Care System

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Keywords

  • Cerebral Palsy
  • CP
  • TMS
  • repetitive Transcranial Magnetic Stimulation
  • Transcranial Magnetic Stimulation
  • rTMS
  • TMS-EEG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Cook Children's Health Care System on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.