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

NCT07567053 | Not Yet Recruiting FDA Device

• 1 other identifier: 2024-100
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change on TMS-evoked potentials (TEPs)

  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 Outcomes (1)

• Change on cortical excitability - motor evoked potentials (MEPs)

  Within the end of 4 weeks and 1-month follow-up of sham/real rTMS

Other Outcomes (9)

• Modified Ashworth Scale (MAS)

  Within the end of 4 weeks and 1-month follow-up of sham/real rTMS

• Mirror Movement Assessment

  Within the end of 4 weeks and 1-month follow-up of sham/real rTMS

• Gross Motor Function Measure (GMFM-88)

  Within the end of 4 weeks and 1-month follow-up of sham/real rTMS

Study Arms (4)

Intervention Group 1

EXPERIMENTAL

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; Device: HD-EEG Recording; Device: rTMS

Intervention Group 2

EXPERIMENTAL

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; Device: HD-EEG Recording; Device: rTMS

Sham Group

SHAM COMPARATOR

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; Device: HD-EEG Recording; Device: rTMS

Control Group

ACTIVE COMPARATOR

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; Device: HD-EEG Recording

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.

Control Group; Intervention Group 1; Intervention Group 2; Sham Group

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).

Control Group; Intervention Group 1; Intervention Group 2; Sham Group

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.

Intervention Group 1; Intervention Group 2; Sham Group

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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.
• 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,

Sponsors & Collaborators

• Cook Children's Health Care System: lead

Study Sites (1)

Cook Children's Hospital

Fort Worth, Texas, 76107, United States

Location

Related Publications (60)

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MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Christos Papadelis, PhD

  Cook Children's Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christos Papadelis, PhD

CONTACT

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

Behnam Ghabel Damirchi, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

US (1)