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

May 12, 2026 updated by: Cook Children's Health Care System

6-Hz Primed Low and High-Frequency Repetitive Transcranial Magnetic Stimulation on Motor Function and Meta-Plasticity in Children With Cerebral Palsy: TMS-EEG Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cerebral Palsy (CP) is a neurodevelopmental condition marked by motor impairments that affect both upper and lower limbs. This project investigates the therapeutic benefits, safety, and tolerability of repetitive transcranial magnetic stimulation (rTMS) for improving motor function and meta-plasticity (re-organization) in children with CP. Specifically, the study investigates the effects of 6-Hz primed low and high-frequency rTMS on neural motor function and meta-plasticity, utilizing TMS-EEG as a core method for assessing motor evoked potentials (MEPs) and TMS-evoked potentials (TEPs). Through modulating cortical excitability, the investigators expect that 6-Hz primed low and high-frequency rTMS will improve motor function and generate meta-plasticity in children with CP. This improvement in motor and induced meta-plasticity potentially leads to faster rehabilitation outcomes and reduced need for long-term care, which would benefit both patients and hospital systems by lowering treatment costs and improving resource allocation.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76107
        • Cook Children's Hospital
        • Contact:
        • Sub-Investigator:
          • Behnam G Ghabel Damirchi, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.
Device: 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.
Device: 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).
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.
Device: 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.
Device: 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.
Device: 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).
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.
Device: 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.
Device: 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.
Device: 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).
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.
Device: 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.
Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on TMS-evoked potentials (TEPs)
Time Frame: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
TEPs refer to the electrical responses in the brain elicited by rTMS. This technique involves applying magnetic pulses to specific brain areas, which induce electrical activity that can be recorded using EEG.
Within the end of 4 weeks and 1-month follow-up of sham/real rTMS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on cortical excitability - motor evoked potentials (MEPs)
Time Frame: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
MEPs are electrical signals generated by stimulating the brain's motor cortex and recorded from muscles.
Within the end of 4 weeks and 1-month follow-up of sham/real rTMS

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale (MAS)
Time Frame: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
The Modified Ashworth Scale assesses spasticity in patients with central nervous system lesions or neurological disorders. It provides a rapid and straightforward method for clinicians to evaluate spasticity while performing passive soft-tissue stretches.
Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
Mirror Movement Assessment
Time Frame: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
This evaluates the presence and severity of involuntary mirror movements, where movement in one limb is mirrored by involuntary movement in the opposite limb. It provides a structured approach to quantify and monitor these movements, helping to gauge the impact of therapeutic interventions and track changes over time.
Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
Gross Motor Function Measure (GMFM-88)
Time Frame: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
It is a standardized observational tool specifically created and validated to assess changes in gross motor function over time in children with CP. The GMFM-88 allows for the summation of item scores to generate raw and percentage scores for each of the five GMFM dimensions, the selected goal areas, and an overall GMFM-88 score.
Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
Adverse effects
Time Frame: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
Adverse effects of TMS-EEG can include temporary headaches, scalp discomfort, and mild skin irritation from EEG electrodes. Rarely, individuals might experience transient cognitive effects or muscle twitching. There is also a minimal risk of inducing seizures, particularly in those with a history of epilepsy.
Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
Finger Tapping Task
Time Frame: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
A keyboard tapping task measuring low-level motor ability and psychomotor speed. Modeled after the Finger Tapping or Oscillation task from the Reitan Test Battery. Participants tap a key as quickly as possible for multiple trials, testing dominant and/or non-dominant hand.
Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
Task Fitt's Law Task
Time Frame: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
Classic motor control task measuring the speed-accuracy tradeoff in rapid aimed movements. Tests the relationship between movement time, distance, and target size, following Fitts' Law (MT = a + b*log2(2D/W)). Participants rapidly move the mouse cursor from a home position to rectangular targets of varying sizes and distances. Each trial begins at the home position on the left side of the screen. When ready, participants move to the target rectangle as quickly as possible. Movement time and accuracy are recorded for each trial.
Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
Pursuit Rotor
Time Frame: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
Motor tracking task requiring continuous tracking of a moving target with mouse or touch input. Measures motor coordination and learning.
Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
Time Tapping Task
Time Frame: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
Motor timing task measuring self-paced tapping consistency across multiple trials. Participants tap at a self-paced even rate following a visual entrainment period. After seeing a flashing cross that demonstrates the target tapping rate, participants must maintain that rhythm for a sustained period (default 180 seconds per trial). The task assesses low-level motor timing ability and may be sensitive to fatigue, sleep deprivation, and motor control deficits.
Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
Simple Reaction Time
Time Frame: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
A simple reaction time task where a single stimulus (an 'X' or mouse button prompt) appears at a specifiable delay from the previous response. Measures basic alertness and motor response speed across multiple blocks with breaks.
Within the end of 4 weeks and 1-month follow-up of sham/real rTMS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Children's Health Care System

Investigators

  • Principal Investigator: Christos Papadelis, PhD, Cook Children's Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-100 (Comité Etico Cientifico Facultad de Medicina Universidad del Desarrollo Clínica Alemana)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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