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RECRUITING
NCT07834333
NA

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

Sponsor: Ankara Etlik City Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Effects of Different Theta Burst Stimulation Protocols Combined With Conventional Rehabilitation on Upper and Lower Extremity Motor Recovery in Patients With Early-Stage Stroke

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-09-30

Completion Date

2027-09-30

Last Updated

2026-09-22

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Continuous Theta Burst Stimulation (cTBS)

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.

DEVICE

Intermittent Theta Burst Stimulation (iTBS)

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.

DEVICE

Sham Continuous Theta Burst Stimulation

Sham continuous theta burst stimulation will be delivered over the contralesional primary motor cortex using a sham coil for 40 seconds.

DEVICE

Sham Intermittent Theta Burst Stimulation

Sham intermittent theta burst stimulation will be delivered over the ipsilesional primary motor cortex using a sham coil for approximately 190 seconds.

Locations (1)

Ankara Etlik Şehir Hastanesi

Ankara, Yenimahalle, Turkey (Türkiye)