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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07567053
Enrollment
60
Registered
2026-05-05
Start date
2026-05-01
Completion date
2030-06-01
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Typically Developing Children

Keywords

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

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.

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.

Interventions

DEVICEMRI

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.

DEVICEHD-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).

DEVICErTMS

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.

Sponsors

Cook Children's Health Care System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 20 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change on TMS-evoked potentials (TEPs)Within the end of 4 weeks and 1-month follow-up of sham/real rTMSTEPs 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

MeasureTime frameDescription
Change on cortical excitability - motor evoked potentials (MEPs)Within the end of 4 weeks and 1-month follow-up of sham/real rTMSMEPs are electrical signals generated by stimulating the brain's motor cortex and recorded from muscles.

Countries

United States

Contacts

CONTACTChristos Papadelis, PhD
Christos.Papadelis@cookchildrens.org682-305-3236
CONTACTBehnam Ghabel Damirchi, MSc
behnam.ghabeldamirchi@cookchildrens.org682-367-3956
PRINCIPAL_INVESTIGATORChristos Papadelis, PhD

Cook Children's Health Care System

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026