Repetitive Transcranial Magnetic Stimulation Combined With Motor Rehabilitation Improves Motor and Functional Outcomes After Ischemic Stroke
NCT07369648 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2026-02-10
Summary
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.
Conditions
- Ischemic Stroke
- Hemiplegia
- Motor Function Impairment
Interventions
- DEVICE
-
Active repetitive transcranial magnetic stimulation
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.
- DEVICE
-
Sham repetitive transcranial magnetic stimulation
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).
- OTHER
-
Conventional motor rehabilitation
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.
Sponsors & Collaborators
-
Hanoi Medical University
lead OTHER
Principal Investigators
-
Loan Phan Thi Kieu, MD, MSc · Hanoi Medical University, Hanoi, Vietnam
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-28
- Primary Completion
- 2027-06-30
- Completion
- 2028-12-31
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