Repetitive Transcranial Magnetic Stimulation on Motor Function and Meta-Plasticity in Cerebral Palsy: TMS-EEG Study
12 мая 2026 г. обновлено: Cook Children's Health Care System
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
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.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
60
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Behnam Ghabel Damirchi, MSc
- Номер телефона: 682-367-3956
- Электронная почта: behnam.ghabeldamirchi@cookchildrens.org
Учебное резервное копирование контактов
- Имя: Christos Papadelis, PhD
- Номер телефона: 682-305-3236
- Электронная почта: Christos.Papadelis@cookchildrens.org
Места учебы
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Texas
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Fort Worth, Texas, Соединенные Штаты, 76107
- Cook Children's Hospital
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Контакт:
- Dr. Christos Papadelis, PhD, PhD
- Номер телефона: 682-305-3236
- Электронная почта: Christos.Papadelis@cookchilrens.org
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Младший исследователь:
- Behnam G Ghabel Damirchi, MSc
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Да
Описание
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.
Exclusion Criteria (TD):
- 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,
- Limb contractures caused by injury,
- 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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Intervention Group 1
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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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.
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.
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).
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Экспериментальный: Intervention Group 2
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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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.
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.
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).
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Фальшивый компаратор: Sham Group
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.
|
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.
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.
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).
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Активный компаратор: Control Group
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.
|
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).
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change on TMS-evoked potentials (TEPs)
Временное ограничение: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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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.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change on cortical excitability - motor evoked potentials (MEPs)
Временное ограничение: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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MEPs are electrical signals generated by stimulating the brain's motor cortex and recorded from muscles.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Modified Ashworth Scale (MAS)
Временное ограничение: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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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.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Mirror Movement Assessment
Временное ограничение: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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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.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Gross Motor Function Measure (GMFM-88)
Временное ограничение: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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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.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Adverse effects
Временное ограничение: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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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.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Finger Tapping Task
Временное ограничение: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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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.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Task Fitt's Law Task
Временное ограничение: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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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.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Pursuit Rotor
Временное ограничение: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Motor tracking task requiring continuous tracking of a moving target with mouse or touch input.
Measures motor coordination and learning.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Time Tapping Task
Временное ограничение: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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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.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Simple Reaction Time
Временное ограничение: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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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.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Christos Papadelis, PhD, Cook Children's Health Care System
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 мая 2026 г.
Первичное завершение (Оцененный)
1 мая 2028 г.
Завершение исследования (Оцененный)
1 июня 2030 г.
Даты регистрации исследования
Первый отправленный
28 апреля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
28 апреля 2026 г.
Первый опубликованный (Действительный)
5 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
14 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
12 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2024-100 (Comité Etico Cientifico Facultad de Medicina Universidad del Desarrollo Clínica Alemana)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕ РЕШЕНО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Да
продукт, произведенный в США и экспортированный из США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .