rTMS plus rehabilitation for motor recovery after ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, sham-controlled study compares 1 Hz repetitive transcranial magnetic stimulation plus conventional motor rehabilitation to sham rTMS with the same rehabilitation in adults with a first-ever ischemic stroke and unilateral hemiparesis. Participants are enrolled across acute, subacute, and chronic stages and receive 20 daily sessions (five days per week) before rehabilitation, targeting the contralesional motor cortex for upper limbs and the leg area for gait-related training. Outcomes include motor function, balance, functional mobility, activities of daily living, and stroke-specific quality of life. The trial uses standardized rehabilitation for all participants to isolate the potential added benefit of rTMS.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hanoi Rehabilitation Hospital
  Hanoi, Vietnam Recruiting

Study contacts

• Principal investigator: Loan Phan Thi Kieu, MD, MSc — Hanoi Medical University, Hanoi, Vietnam
• Study coordinator: Loan Phan Thi Kieu, MD, MSc
• Email: phanthikieuloan@hmu.edu.vn
• Phone: +84 975309081

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.