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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Ancor Rebassa Cabrera • ClinicalTrials.gov ID: NCT07787793

Registry updated: 2026-08-26
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Description

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.

Interventions

  • 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.
  • 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.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Conditions

Stroke Upper Limb Paresis

Locations

  • Hospital Sant Joan de Déu Palma — Palma, Balearic Islands, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record