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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-20
SponsorCook Children's Health Care System

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

Syndromic or genetic brain-related associations,

History of major trauma or brain surgery,

Inability to remain still,

History of Epilepsy,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Intervention Group 1Experimental treatment 3 interventions
Group B: Intervention Group 2Experimental treatment 3 interventions
Group C: Sham GroupSham comparator 3 interventions
Group D: Control GroupActive comparator 2 interventions

Trial outcomes

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.

Time frame
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)

MEPs are electrical signals generated by stimulating the brain's motor cortex and recorded from muscles.

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

Other outcomes

1

Modified Ashworth Scale (MAS)

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.

Time frame
Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
2

Mirror Movement Assessment

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.

Time frame
Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
3

Gross Motor Function Measure (GMFM-88)

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.

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

Adverse effects

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.

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

Sponsors and contacts

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