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

Sponsor
Ancor Rebassa Cabrera
Study ID
NCT07787793
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Aug 26, 2026
Start date
Sep 15, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Intervention group
    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).
  • Sham Comparator: Control group
    Participants receive cortical motor mapping (pre-intervention), a single session of sham stimulation, and cortical motor mapping (post-intervention).

Primary Outcome Measure

Number of MEP-positive points in the cortical motor map (Area) [ Time Frame: Immediately before and immediately after a single rTMS or sham session (same day) ]

Central Contacts

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