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NCT Number: NCT07567053

Repetitive Transcranial Magnetic Stimulation on Motor Function and Meta-Plasticity in 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.

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Key information

Age range

6 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cook Children's Hospital

Fort Worth, Texas, 76107, United States

Location contact

Behnam G Ghabel Damirchi, MSc

SUB_INVESTIGATOR

Dr. Christos Papadelis, PhD, PhD

CONTACT

[email protected]

682-305-3236

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Behnam Ghabel Damirchi, MSc

CONTACT

[email protected]

682-367-3956

Christos Papadelis, PhD

CONTACT

[email protected]

682-305-3236

Sponsors and collaborators

Lead sponsor

Cook Children's Health Care System

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
May 5, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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