Repetitive Transcranial Magnetic Stimulation on Motor Function and Meta-Plasticity in Cerebral Palsy: TMS-EEG Study

Официальное название

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

Обзор

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.

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.

Вмешательства

• Устройство MRI
  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.
• Устройство HD-EEG Recording
  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).
• Устройство rTMS
  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.

Первичные конечные точки

• Change on TMS-evoked potentials (TEPs) [Срок оценки: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS]

Вторичные конечные точки (1)

• Change on cortical excitability - motor evoked potentials (MEPs) [Срок оценки: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Cook Children's Hospital — Fort Worth

Публикации

• 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. PMID 32659484
• 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. PMID 27771347
• Iversen, J. R. & Makeig, S. MEG/EEG data analysis using EEGLAB. Magnetoencephalography: From signals to dynamic cortical networks 391-406 (2019).
• Tadel F, Baillet S, Mosher JC, Pantazis D, Leahy RM. Brainstorm: a user-friendly application for MEG/EEG analysis. Comput Intell Neurosci. 2011;2011:879716. doi: 10.1155/2011/879716. Epub 2011 Apr 13. PMID 21584256
• Croarkin PE, Wall CA, Lee J. Applications of transcranial magnetic stimulation (TMS) in child and adolescent psychiatry. Int Rev Psychiatry. 2011 Oct;23(5):445-53. doi: 10.3109/09540261.2011.623688. PMID 22200134
• Gilbert DL, Garvey MA, Bansal AS, Lipps T, Zhang J, Wassermann EM. Should transcranial magnetic stimulation research in children be considered minimal risk? Clin Neurophysiol. 2004 Aug;115(8):1730-9. doi: 10.1016/j.clinph.2003.10.037. PMID 15261851
• Zewdie E, Ciechanski P, Kuo HC, Giuffre A, Kahl C, King R, Cole L, Godfrey H, Seeger T, Swansburg R, Damji O, Rajapakse T, Hodge J, Nelson S, Selby B, Gan L, Jadavji Z, Larson JR, MacMaster F, Yang JF, Barlow K, Gorassini M, Brunton K, Kirton A. Safety and tolerability of transcranial magnetic and direct current stimulation in children: Prospective single center evidence from 3.5 million stimulati PMID 32289678
• Lerner AJ, Wassermann EM, Tamir DI. Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. Clin Neurophysiol. 2019 Aug;130(8):1409-1416. doi: 10.1016/j.clinph.2019.03.016. Epub 2019 Apr 6. PMID 31104898

Идентификаторы

NCT: NCT07567053 · 2024-100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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