Repetitive Transcranial Magnetic Stimulation for Motor Recovery After Ischemic Stroke (rTMS-MOTOR)

ConditionsIschemic Stroke Hemiplegia Motor Function Impairment

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorHanoi Medical University

About this trial

Ischemic stroke is a leading cause of long-term motor disability, frequently resulting in hemiplegia and limitations in daily activities and quality of life. Motor rehabilitation is a fundamental component of post-stroke care across all stages of recovery; however, functional outcomes may vary, particularly in patients with persistent motor impairment.

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that has been used as an adjunct to rehabilitation to modulate cortical excitability and potentially support motor recovery.

The purpose of this study is to evaluate the effects of low-frequency rTMS combined with conventional motor rehabilitation compared with sham rTMS combined with conventional motor rehabilitation in patients with first-ever ischemic stroke during the acute, subacute, and chronic stages. Motor function, balance, functional mobility, activities of daily living, and stroke-specific quality of life will be assessed at baseline, after the intervention, and at 3-month and 6-month follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 80 years.

Diagnosed with a first-ever ischemic stroke, confirmed by neuroimaging.

Presence of unilateral hemiparesis attributable to the first-ever ischemic stroke.

Acute stage: < 1 month after stroke onset

Disqualifiers

Motor impairment caused by conditions other than ischemic stroke, such as musculoskeletal disorders, traumatic brain injury, Parkinson's disease, encephalitis, or other neurological conditions.

Contraindications to repetitive transcranial magnetic stimulation, including but not limited to intracranial metallic implants, implanted electronic medical devices (e.g., pacemaker), cochlear implants, known bleeding disorders, pregnancy, history of epilepsy or seizure disorders, severe cardiac disease, severe psychiatric or neurological disorders interfering with participation, or active skin conditions at the stimulation site.

History of epilepsy or seizure disorders.

Recurrent stroke occurring during the intervention period.

Trial design

Design model

Parallel

Treatments tested in this trial

Active repetitive transcranial magnetic stimulation
Device
Active rTMS is delivered at low frequency (1 Hz), 1200 pulses per session, 20 minutes per session, once daily, five days per week, for four consecutive weeks (20 sessions). rTMS is administered immediately prior to the daily conventional rehabilitation session. Upper limb target: Stimulation is applied to the M1 hand area using a figure-of-eight coil. The stimulation site is identified using standard localization methods (EEG 10-20 system landmarks and/or motor evoked potentials when available). Lower limb target: Stimulation is applied to the M1 leg area located near the cranial midline using a Hesed coil, with localization based on midline landmarks (near Cz) and/or motor evoked potentials from lower limb muscles when available. Stimulation intensity is set relative to the individual motor threshold.
Sham repetitive transcranial magnetic stimulation
Device
Sham rTMS is administered using the same procedures, participant positioning, coil placement, stimulation duration (20 minutes), and acoustic cues as the active stimulation protocol. To minimize effective cortical stimulation, the coil is oriented perpendicular to the scalp, producing minimal magnetic field penetration while preserving the characteristic clicking sound. Sham sessions follow the same schedule as active rTMS (once daily, five days per week, for four consecutive weeks; 20 sessions).
Conventional motor rehabilitation
Other intervention
Participants receive standardized conventional motor rehabilitation for 60 minutes per day, five days per week, for four consecutive weeks. Each daily session includes three components: therapeutic exercise (approximately 20 minutes), physical therapy modalities (approximately 20 minutes), and occupational therapy/task-oriented functional training (approximately 20 minutes). The rehabilitation program is identical in content, intensity, and duration for both study arms.

Treatment groups

66 Participants

are divided into 2 treatment groups

Group A: Control GroupPlacebo comparator 2 interventions

Group B: Intervention GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Change in upper limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UL)

The Fugl-Meyer Assessment for Upper Extremity (FMA-UL) is a validated scale for evaluating motor impairment of the upper limb after stroke. Scores range from 0 to 66, with higher scores indicating better motor function.

Time frame