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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change on cortical excitability - motor evoked potentials (MEPs) | MEPs are electrical signals generated by stimulating the brain's motor cortex and recorded from muscles. | Within the end of 4 weeks and 1-month follow-up of sham/real rTMS |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within the end of 4 weeks and 1-month follow-up of sham/real rTMS |
Inclusion Criteria (CP):
Inclusion Criteria (TD):
Exclusion Criteria (CP):
Exclusion Criteria (TD):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christos Papadelis, PhD | Contact | 682-305-3236 | Christos.Papadelis@cookchildrens.org | |
| Behnam Ghabel Damirchi, MSc | Contact | 682-367-3956 | behnam.ghabeldamirchi@cookchildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Christos Papadelis, PhD | Cook Children's Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cook Children's Hospital | Fort Worth | Texas | 76107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32659484 | Background | Mutanen TP, Biabani M, Sarvas J, Ilmoniemi RJ, Rogasch NC. Source-based artifact-rejection techniques available in TESA, an open-source TMS-EEG toolbox. Brain Stimul. 2020 Sep-Oct;13(5):1349-1351. doi: 10.1016/j.brs.2020.06.079. Epub 2020 Jul 10. No abstract available. | |
| 27771347 | Background | Rogasch NC, Sullivan C, Thomson RH, Rose NS, Bailey NW, Fitzgerald PB, Farzan F, Hernandez-Pavon JC. Analysing concurrent transcranial magnetic stimulation and electroencephalographic data: A review and introduction to the open-source TESA software. Neuroimage. 2017 Feb 15;147:934-951. doi: 10.1016/j.neuroimage.2016.10.031. Epub 2016 Oct 20. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 26, 2026 | Apr 9, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form (CP) | Mar 26, 2026 | Apr 9, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form (TD) | Mar 26, 2026 | Apr 9, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
|
| 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. |
|
| 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. | Within the end of 4 weeks and 1-month follow-up of sham/real rTMS |
| 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. | Within the end of 4 weeks and 1-month follow-up of sham/real rTMS |
| 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. | Within the end of 4 weeks and 1-month follow-up of sham/real rTMS |
| Finger Tapping Task | 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. | Within the end of 4 weeks and 1-month follow-up of sham/real rTMS |
| Task Fitt's Law Task | 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. | Within the end of 4 weeks and 1-month follow-up of sham/real rTMS |
| Pursuit Rotor | Motor tracking task requiring continuous tracking of a moving target with mouse or touch input. Measures motor coordination and learning. | Within the end of 4 weeks and 1-month follow-up of sham/real rTMS |
| Time Tapping Task | 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. | Within the end of 4 weeks and 1-month follow-up of sham/real rTMS |
| Simple Reaction Time | 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. | Within the end of 4 weeks and 1-month follow-up of sham/real rTMS |
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