Effects of High-Frequency rTMS on Cortical Motor Mapping in Stroke Patients With Severe Upper Limb Impairment (MAP2024SJD)

NCT07787793 | Recruiting

• 1 other identifier: IB5708/25 PS
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a single session of high-frequency repetitive transcranial magnetic stimulation (rTMS) can increase cortical motor activity in stroke patients with severe upper limb impairment. The main question it aims to answer is: Does one session of high-frequency rTMS increase the number of motor evoked potential (MEP)-positive points in the cortical motor map of the affected hemisphere compared to sham stimulation? Researchers will compare high-frequency rTMS (10 Hz, 600 pulses) applied over the affected motor cortex to sham stimulation to see if rTMS increases detectable cortical motor responses in patients who have little or no voluntary hand movement after stroke. Participants will: Undergo a cortical motor mapping assessment before the intervention. Receive either one session of real rTMS or sham stimulation, depending on their randomly assigned group. Undergo a second cortical motor mapping assessment immediately after the intervention.

Conditions

Stroke; Upper Limb Paresis

Keywords

stroke; transcranial magnetic stimulation; rtms; cortical motor mapping; motor evoked potential; neuroplasticity; upper limb rehabilitation; neurorrehabilitation; diaschisis

Outcome Measures

Primary Outcomes (1)

• Number of MEP-positive points in the cortical motor map (Area)

  Number of grid positions (5x5 grid, 1 cm spacing, centred on C3/C4 of the affected hemisphere) with a motor evoked potential amplitude of 10 microvolts or greater, recorded from the extensor carpi radialis muscle via surface EMG (UltraPro S100, Natus Medical Inc.) with navigated TMS (Brainsight 2, Rogue Research Inc.). Three biphasic pulses at 100% maximum stimulator output are applied per grid point.

  Immediately before and immediately after a single rTMS or sham session (same day)

Secondary Outcomes (8)

• Maximum MEP amplitude

  Immediately before and immediately after a single rTMS or sham session (same day)

• Cortical map volume

  Immediately before and immediately after a single rTMS or sham session (same day)

• Cortical map centre of gravity

  Immediately before and immediately after a single rTMS or sham session (same day)

• Optimal hotspot coordinates

  Immediately before and immediately after a single rTMS or sham session (same day)

• Fugl-Meyer Assessment - Upper Extremity (FMA-UE)

  Baseline (single assessment, same day as intervention)

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants receive cortical motor mapping (pre-intervention), a single session of high-frequency rTMS over the affected motor cortex, and cortical motor mapping (post-intervention).

Device: High-frequency repetitive transcranial magnetic stimulation

Control group

SHAM COMPARATOR

Participants receive cortical motor mapping (pre-intervention), a single session of sham stimulation, and cortical motor mapping (post-intervention).

Device: Sham transcranial magnetic stimulation

Interventions

Sham transcranial magnetic stimulation DEVICE

Same coil (Magstim Rapid2 / D70mm Air Film) placed at the same position as the active condition but rotated 90 degrees, producing comparable auditory and cutaneous sensations without effective cortical stimulation.

Control group

High-frequency repetitive transcranial magnetic stimulation DEVICE

Single session of 10 Hz rTMS using a Magstim Rapid2 stimulator with a D70mm Air Film figure-of-eight coil. Parameters: 600 pulses in trains of 15 pulses (1.5 s on, 10 s off) at 80% of the motor threshold over the optimal hotspot of the affected hemisphere (or C3/C4 if no MEP-positive point is identified). Parameters are within IFCN safety guidelines.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-ever stroke confirmed by MRI or CT scan.
• Inability to voluntarily activate the hand musculature:
• manual muscle testing score of 1 or less in finger extension.
• Time since stroke onset greater than 6 months.

You may not qualify if:

• History of craniotomy or metallic implants in the skull.
• Diagnosis of uncontrolled epilepsy.
• Diagnosis of other neurological diseases (dementia, Parkinson's disease, neuropathies, multiple sclerosis, or similar conditions).
• Low level of consciousness or significant cognitive impairment that prevents informed consent or study collaboration.
• Diagnosis of rheumatic disease or presence of hand deformities.
• Pregnancy.

Sponsors & Collaborators

• Ancor Rebassa Cabrera: lead

Study Sites (1)

Hospital Sant Joan de Déu Palma

Palma, Balearic Islands, 07007, Spain

RECRUITING

Related Publications (5)

• Krieg SM, Lioumis P, Makela JP, Wilenius J, Karhu J, Hannula H, Savolainen P, Lucas CW, Seidel K, Laakso A, Islam M, Vaalto S, Lehtinen H, Vitikainen AM, Tarapore PE, Picht T. Protocol for motor and language mapping by navigated TMS in patients and healthy volunteers; workshop report. Acta Neurochir (Wien). 2017 Jul;159(7):1187-1195. doi: 10.1007/s00701-017-3187-z. Epub 2017 Apr 29.

  PMID: 28456870 BACKGROUND

• Bai Z, Zhang J, Fong KNK. Effects of transcranial magnetic stimulation in modulating cortical excitability in patients with stroke: a systematic review and meta-analysis. J Neuroeng Rehabil. 2022 Feb 22;19(1):24. doi: 10.1186/s12984-022-00999-4.

  PMID: 35193624 BACKGROUND

• Leao MT, Naros G, Gharabaghi A. Detecting poststroke cortical motor maps with biphasic single- and monophasic paired-pulse TMS. Brain Stimul. 2020 Jul-Aug;13(4):1102-1104. doi: 10.1016/j.brs.2020.05.005. Epub 2020 May 8.

  PMID: 32418913 BACKGROUND

• Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.

  PMID: 33243615 BACKGROUND

• Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.

  PMID: 31901449 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis; Diaschisis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ancor Rebassa Cabrera, PT, MSc

  Hospital Sant Joan de Deu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ancor Rebassa Cabrera, PT, MSc

CONTACT

+34 607832655; ancor.rebassa@sjd.es

Cristian Sánchez Rodríguez, PT, MSc, PhD

CONTACT

+34 697298533; cristian.sanchez@sjd.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The sham condition uses the same coil rotated 90 degrees at the same position, producing comparable auditory and cutaneous sensations without effective cortical stimulation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist and Coordinator of Therapies, Neurorehabilitation Service

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)