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Cerebral PalsyNCT07567053

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

A study testing MRI, HD-EEG Recording and rTMS in people with Cerebral Palsy and Typically Developing Children, run by Cook Children's Health Care System at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 6 to 20 yearsHealthy volunteers can take part
Conditions the study is for
Cerebral Palsy, Typically Developing Children
What is being tested?
MRI, HD-EEG Recording and rTMS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
27 May 2026to 1 Jun 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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).
  • 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).

Who cannot join

  • 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,
Show all 17Show fewer
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Behnam Ghabel Damirchi, MSc contact

682-367-3956

behnam.ghabeldamirchi@cookchildrens.org

United States1 site, 1 recruiting
  • Cook Children's Hospital

    Fort Worth, Texas, 76107

    Christos Dr. Papadelis, PhD, PhD, 682-305-3236, Christos.Papadelis@cookchilrens.org

    Behnam G Ghabel Damirchi, MSc

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Being tested
MRI, HD-EEG Recording, rTMS
Keywords
Cerebral Palsy, CP, TMS, repetitive Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation, rTMS, TMS-EEG
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIDevice

    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.

  • HD-EEG RecordingDevice

    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).

  • rTMSDevice

    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.

Study groups in NCT07567053
Study groupRoleWhat they receive
Intervention Group 1ExperimentalCP 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.
Receives: Device: MRI; Device: HD-EEG Recording; Device: rTMS
Intervention Group 2ExperimentalCP 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.
Receives: Device: MRI; Device: HD-EEG Recording; Device: rTMS
Sham GroupSham comparatorCP 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.
Receives: Device: MRI; Device: HD-EEG Recording; Device: rTMS
Control GroupActive comparatorTypically 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.
Receives: Device: MRI; Device: HD-EEG Recording

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS

Secondary outcomes (1)
  1. Change on cortical excitability - motor evoked potentials (MEPs)

    MEPs are electrical signals generated by stimulating the brain's motor cortex and recorded from muscles.

    Measured: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start27 May 2026
  3. Primary completion1 May 2028 (estimated)
  4. Study completion1 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07567053
Sponsor's protocol ID
2024-100
Status last verified
Oct 2026
First submitted
28 Apr 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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 stimulations. Brain Stimul. 2020 May-Jun;13(3):565-575. doi: 10.1016/j.brs.2019.12.025. Epub 2019 Dec 30.

    PubMed 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.

    PubMed 31104898
  • Canadian Occupational Performance Measure (COPM) http://www.thecopm.ca/

  • Jebsen-Taylor Hand Function Test (JHFT): http://www.strokengine.ca/assess/jhft/

  • Melbourne Assessment of Unilateral Upper Limb Function (MUUL): Access can be found at http://www.rch.org.au/melbourneassessment/

  • Assessment of Motor and Process Skills (AMPS): Access can be found at http://www.innovativeotsolutions.com/content/amps/

  • Manual Ability Classification System (MACS) http://www.macs.nu/

  • Krumlinde-Sundholm, L. & Eliasson, A.-C. Development of the Assisting Hand Assessment: a Rasch-built measure intended for children with unilateral upper limb impairments. Scand J Occup Ther 10, 16-26 (2003).

  • Harb A, Margetis K, Kishner S. Modified Ashworth Scale. 2025 Apr 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554572/

    PubMed 32119459

Questions about this trial

What is this clinical trial studying?

A study testing MRI, HD-EEG Recording and rTMS in people with Cerebral Palsy and Typically Developing Children, run by Cook Children's Health Care System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christos Papadelis, PhD (682-305-3236, Christos.Papadelis@cookchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change on TMS-evoked potentials (TEPs) (time frame: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07567053, which also lists 60 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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