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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
MRI
DeviceAll 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
DeviceHigh-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
DevicerTMS 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Change on cortical excitability - motor evoked potentials (MEPs)
MEPs are electrical signals generated by stimulating the brain's motor cortex and recorded from muscles.
Other outcomes
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.
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.
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.
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.
Sponsors and contacts
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