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
NCT Number: NCT07567053
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.
Trial opening soon.
Get Notified6 year–20 year
All sexes
Interventional
Not applicable
Fort Worth, Texas, 76107, United States
Behnam G Ghabel Damirchi, MSc
SUB_INVESTIGATOR
Dr. Christos Papadelis, PhD, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(CP):
Inclusion criteria
(TD):
Exclusion criteria
(CP):
Exclusion criteria
(TD):
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Behnam Ghabel Damirchi, MSc
CONTACT
Christos Papadelis, PhD
CONTACT
Cook Children's Health Care System
Other
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
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