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.
First-ever stroke confirmed by MRI or CT scan.
Time since stroke onset greater than 6 months.
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.
Parallel
High-frequency repetitive transcranial magnetic stimulation
DeviceSingle 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
DeviceSame 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.
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.
Maximum MEP amplitude
Maximum peak-to-peak MEP amplitude (microvolts) recorded at any grid point of the cortical motor map.
Cortical map volume
Sum of all MEP amplitudes (microvolts) across all grid points of the cortical motor map.
Cortical map centre of gravity
Amplitude-weighted mean position (MNI/Talairach coordinates) of the cortical motor map, calculated by dividing the amplitude at each grid point by the total map volume.
Optimal hotspot coordinates
MNI/Talairach coordinates of the grid position yielding the highest MEP amplitude.
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Ancor Rebassa Cabrera
Lead sponsor
Fundació Sant Joan de Déu
Sponsor institution
