Repetitive Transcranial Magnetic Stimulation on Motor Function and Meta-Plasticity in Cerebral Palsy: TMS-EEG Study
12 de maio de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Behnam Ghabel Damirchi, MSc
- Número de telefone: 682-367-3956
- E-mail: behnam.ghabeldamirchi@cookchildrens.org
Estude backup de contato
- Nome: Christos Papadelis, PhD
- Número de telefone: 682-305-3236
- E-mail: Christos.Papadelis@cookchildrens.org
Locais de estudo
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Texas
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Fort Worth, Texas, Estados Unidos, 76107
- Cook Children's Hospital
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Contato:
- Dr. Christos Papadelis, PhD, PhD
- Número de telefone: 682-305-3236
- E-mail: Christos.Papadelis@cookchilrens.org
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Subinvestigador:
- Behnam G Ghabel Damirchi, MSc
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Experimental: 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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Comparador Falso: 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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Comparador Ativo: 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.
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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.
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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change on TMS-evoked potentials (TEPs)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change on cortical excitability - motor evoked potentials (MEPs)
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Modified Ashworth Scale (MAS)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Christos Papadelis, PhD, Cook Children's Health Care System
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de maio de 2026
Conclusão Primária (Estimado)
1 de maio de 2028
Conclusão do estudo (Estimado)
1 de junho de 2030
Datas de inscrição no estudo
Enviado pela primeira vez
28 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de abril de 2026
Primeira postagem (Real)
5 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2024-100 (Comité Etico Cientifico Facultad de Medicina Universidad del Desarrollo Clínica Alemana)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Sim
produto fabricado e exportado dos EUA
Não
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