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RECRUITING Not applicable ClinicalTrials.gov

Effectiveness of Theta Burst Stimulation For Upper and Lower Extremity Recovery in Stroke

Sponsor: Ankara Etlik City Hospital • ClinicalTrials.gov ID: NCT07834333

Registry updated: 2026-09-22
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Description

This single-center, single-blind, randomized, sham-controlled clinical trial will include 60 patients aged \>45 years who are within 3 months of a first-ever middle cerebral artery ischemic stroke. Participants will be randomized into four groups: coupled TBS (contralesional cTBS followed by ipsilesional iTBS), cTBS plus sham iTBS, sham cTBS plus iTBS, or sham TBS. TBS will be delivered over the primary motor cortex for 10 sessions over 2 weeks. Stimulation intensity will be set at 80% of the resting motor threshold determined using EMG-guided motor evoked potentials. Each cTBS and iTBS application will consist of 600 pulses. All participants will additionally receive standardized conventional rehabilitation for at least 4 weeks. The primary outcome will be upper-extremity motor recovery assessed using the motor domain of the Fugl-Meyer Assessment. Secondary outcomes will include lower-extremity motor recovery, spasticity, sensory function, cortical excitability, functional ambulation, activities of daily living, and stroke-specific quality of life. Assessments will be performed at baseline, after the 2-week intervention, and at 1-month post-treatment follow-up.

Interventions

  • Continuous Theta Burst Stimulation (cTBS) (Device)
    Continuous theta burst stimulation will be applied over the contralesional primary motor cortex (M1) at 80% of the resting motor threshold. A total of 600 pulses will be delivered over 40 seconds as triplets at 50 Hz repeated every 200 ms.
  • Intermittent Theta Burst Stimulation (iTBS) (Device)
    Intermittent theta burst stimulation will be applied over the ipsilesional primary motor cortex (M1) at 80% of the resting motor threshold. A total of 600 pulses will be delivered over approximately 190 seconds using 2-second trains repeated every 10 seconds.
  • Sham Continuous Theta Burst Stimulation (Device)
    Sham continuous theta burst stimulation will be delivered over the contralesional primary motor cortex using a sham coil for 40 seconds.
  • Sham Intermittent Theta Burst Stimulation (Device)
    Sham intermittent theta burst stimulation will be delivered over the ipsilesional primary motor cortex using a sham coil for approximately 190 seconds.

Eligibility criteria

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.

Conditions

Ischemic Stroke

Locations

  • Ankara Etlik Şehir Hastanesi — Ankara, Yenimahalle, Turkey (Türkiye)
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Official Source

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

View Official Record