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

Sponsor: Hanoi Medical University • ClinicalTrials.gov ID: NCT07369648

Registry updated: 2026-09-17

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Description

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.

Interventions

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)
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.

Eligibility criteria

Inclusion Criteria: * 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. * Time since stroke onset: * Acute stage: \< 1 month after stroke onset * Subacute stage: 1 to 6 months after stroke onset * Chronic stage: \> 6 months after stroke onset * Moderate neurological impairment, defined as a baseline NIHSS score between 5 and 14. * Cognitive ability sufficient to understand and follow instructions, indicated by a baseline MMSE score ≥ 20. * Medically stable and able to participate in a structured motor rehabilitation program. * Provided written informed consent prior to study enrollment. * NIHSS and MMSE scores are assessed at baseline only to characterize neurological severity and cognitive status at study entry Exclusion Criteria: * 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. * Refusal to participate, withdrawal of informed consent, or non-adherence to the intervention protocol.

Conditions

Ischemic Stroke Hemiplegia Motor Function Impairment

Locations

Hanoi Rehabilitation Hospital — Hanoi, Vietnam

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Official Source

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

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