Theta Burst Stimulation to Help Stroke Recovery (Upper and Lower Limbs)

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 is a single-center, single-blind, randomized, sham-controlled study enrolling 60 participants within 3 months of a first MCA stroke. Participants are assigned to one of four groups receiving real or sham continuous and/or intermittent theta burst stimulation over the primary motor cortex for 10 sessions in two weeks, at 80% of the resting motor threshold. All participants also receive conventional rehabilitation for at least four weeks. The trial’s primary outcome is upper-extremity motor recovery measured by the motor domain of the Fugl-Meyer Assessment, with secondary outcomes including lower-extremity motor function, spasticity, sensory function, cortical excitability, and functional ambulation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of ischemic stroke due to middle cerebral artery (MCA) occlusion confirmed by magnetic resonance imaging (MRI).
* Within the first 3 months after stroke.
* First-ever stroke.
* Age ≥45 years.
* Brunnstrom stage 1, 2, or 3 for the upper extremity and hand.
* No previous physical therapy after the current stroke.
* Ability to maintain at least minimal semi-sitting balance.
* Medically and neurologically stable.
* Mini-Mental State Examination score \>24.
* Native Turkish speaker who voluntarily agrees to participate and provides written informed consent.

Exclusion Criteria:

* History of epilepsy.
* Presence of a pacemaker.
* Pregnancy.
* Neurological disease other than stroke.
* Metallic implants in the brain or scalp, including cochlear implants.
* History of brain surgery.
* Comorbid disease that may significantly impair general health, such as heart f-failure or chronic obstructive pulmonary disease, and/or severe infection.
* Diagnosis of malignancy.
* Peripheral nerve injury and/or musculoskeletal disorder affecting motor function of the upper or lower extremities, such as fracture.
* Cardiac arrhythmia.
* Aphasia, spatial neglect, or visual field loss.
* Visual or hearing impairment that prevents communication.
* Alcohol and/or drug dependence.
* Refusal to participate or failure to provide informed consent.

Where it's running

• Ankara Etlik Şehir Hastanesi
  Ankara, Yenimahalle, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Fatma Melis Ertuğrul Öztürk, Resident
• Email: melis.ertugrul@hotmail.com
• Phone: 03127970000

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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.