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Effects of Repetitive Transcranial Magnetic Stimulation Combined With Motor Rehabilitation on Motor and Functional Outcomes in Patients With Ischemic Stroke: A Randomized Sham-Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Viet Nam
Hanoi Rehabilitation Hospital
RECRUITING
Hanoi
Contact Information
Primary
Loan Phan Thi Kieu, MD, MSc
phanthikieuloan@hmu.edu.vn
+84 975309081
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2028-12
Participants
Target number of participants: 66
Treatments
Placebo_comparator: Control Group
Participants receive sham rTMS combined with the same standardized conventional motor rehabilitation program. Sham stimulation uses identical procedures, participant positioning, coil placement, session duration, and acoustic cues as active rTMS, but with the coil oriented perpendicular to the scalp to minimize effective cortical stimulation
Experimental: Intervention Group
Participants receive active low-frequency repetitive transcranial magnetic stimulation (rTMS) combined with standardized conventional motor rehabilitation targeting both upper and lower limb function. Active rTMS targets the primary motor cortex (M1) representations relevant to the upper limb (hand area) and lower limb (leg area), with stimulation parameters delivered according to the predefined protocol.
Sponsors
Leads: Hanoi Medical University

This content was sourced from clinicaltrials.gov