Effectiveness of Theta Burst Stimulation For Upper and Lower Extremity Recovery in Stroke
Effects of Different Theta Burst Stimulation Protocols Combined With Conventional Rehabilitation on Upper and Lower Extremity Motor Recovery in Patients With Early-Stage Stroke
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2026
CompletedFirst Posted
Study publicly available on registry
September 22, 2026
CompletedStudy Start
First participant enrolled
September 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
September 22, 2026
August 1, 2026
11 months
August 28, 2026
September 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment - Upper Extremity Motor Subscale (FMA-UE)
Upper extremity motor function will be assessed using the motor subsection of the Fugl-Meyer Assessment. The FMA-UE motor score ranges from 0 to 66, with higher scores indicating better upper extremity motor function. Each item is scored on a 3-point ordinal scale: 0 = cannot perform, 1 = performs partially, and 2 = performs fully
Baseline, Week 2, and Week 6
Change in Lower Extremity Motor Function Assessed by the Fugl-Meyer Assessment - Lower Extremity Motor Subscale
Lower extremity motor recovery will be assessed using the lower extremity motor subsection of the Fugl-Meyer Assessment.
Baseline, Week 2, and Week 6
Change in Motor Recovery Stage Assessed by the Brunnstrom Motor Recovery Stages
Motor recovery of the upper and lower extremities will be evaluated using the Brunnstrom Motor Recovery Stages. Each assessed region is rated separately from stage I (1) to stage VI (6), with higher stages indicating better motor recovery.
Baseline, Week 2, and Week 6
Secondary Outcomes (7)
Change in Spasticity Assessed by the Modified Ashworth Scale
Baseline, Week 2, and Week 6
Change in Sensory Function Assessed by the Fugl-Meyer Assessment - Sensory Subscale
Baseline, Week 2, and Week 6
Change in Cortical Excitability Assessed by Motor Evoked Potential Amplitude
Baseline, Week 2, and Week 6
Change in Cortical Excitability Assessed by Motor Evoked Potential Latency
Baseline, Week 2, and Week 6
Change in Functional Ambulation Assessed by the Functional Ambulation Scale
Baseline, Week 2, and Week 6
- +2 more secondary outcomes
Study Arms (4)
Coupled TBS Group
EXPERIMENTALParticipants will receive contralesional continuous theta burst stimulation (cTBS) followed by ipsilesional intermittent theta burst stimulation (iTBS) within the same session. Ten sessions will be administered over 2 weeks in addition to standardized conventional rehabilitation.
cTBS + Sham iTBS Group
EXPERIMENTALParticipants will receive contralesional continuous theta burst stimulation (cTBS) followed by ipsilesional sham intermittent theta burst stimulation (sham iTBS) within the same session. Ten sessions will be administered over 2 weeks in addition to standardized conventional rehabilitation.
Sham cTBS + iTBS Group
EXPERIMENTALParticipants will receive contralesional sham continuous theta burst stimulation (sham cTBS) followed by ipsilesional intermittent theta burst stimulation (iTBS) within the same session. Ten sessions will be administered over 2 weeks in addition to standardized conventional rehabilitation.
Sham TBS Group
SHAM COMPARATORParticipants will receive contralesional sham continuous theta burst stimulation (sham cTBS) followed by ipsilesional sham intermittent theta burst stimulation (sham iTBS) within the same session. Ten sessions will be administered over 2 weeks in addition to standardized conventional rehabilitation.
Interventions
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 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 will be delivered over the contralesional primary motor cortex using a sham coil for 40 seconds.
Sham intermittent theta burst stimulation will be delivered over the ipsilesional primary motor cortex using a sham coil for approximately 190 seconds.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Etlik Şehir Hastanesi
Ankara, Yenimahalle, 06170, Turkey (Türkiye)
Related Publications (5)
Long H, Wang H, Zhao C, Duan Q, Feng F, Hui N, Mao L, Liu H, Mou X, Yuan H. Effects of combining high- and low-frequency repetitive transcranial magnetic stimulation on upper limb hemiparesis in the early phase of stroke. Restor Neurol Neurosci. 2018;36(1):21-30. doi: 10.3233/RNN-170733.
PMID: 29439359BACKGROUNDKuzu O, Adiguzel E, Kesikburun S, Yasar E, Yilmaz B. The Effect of Sham Controlled Continuous Theta Burst Stimulation and Low Frequency Repetitive Transcranial Magnetic Stimulation on Upper Extremity Spasticity and Functional Recovery in Chronic Ischemic Stroke Patients. J Stroke Cerebrovasc Dis. 2021 Jul;30(7):105795. doi: 10.1016/j.jstrokecerebrovasdis.2021.105795. Epub 2021 Apr 20.
PMID: 33887662BACKGROUNDChen Q, Shen D, Sun H, Ke J, Wang H, Pan S, Liu H, Wang D, Su M, Fang Q. Effects of coupling inhibitory and facilitatory repetitive transcranial magnetic stimulation on motor recovery in patients following acute cerebral infarction. NeuroRehabilitation. 2021;48(1):83-96. doi: 10.3233/NRE-201606.
PMID: 33361618BACKGROUNDFu Y, Wang C, Zhang L, Ji D, Xiang A, Qi J, Zhao R, Wu L, Jin S, Zhang Q. The effectiveness of theta burst stimulation for motor recovery after stroke: a systematic review. Eur J Med Res. 2024 Nov 29;29(1):568. doi: 10.1186/s40001-024-02170-2.
PMID: 39609900BACKGROUNDMeng Y, Zhang D, Hai H, Zhao YY, Ma YW. Efficacy of coupling intermittent theta-burst stimulation and 1 Hz repetitive transcranial magnetic stimulation to enhance upper limb motor recovery in subacute stroke patients: A randomized controlled trial. Restor Neurol Neurosci. 2020;38(1):109-118. doi: 10.3233/RNN-190953.
PMID: 32039879BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants and the TMS operator administering the stimulation will be blinded to group allocation. Sham stimulation will be delivered using a sham coil designed to mimic the corresponding active TBS procedures, thereby maintaining blinding of both participants and the TMS operator throughout the intervention.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- pm&r specialist
Study Record Dates
First Submitted
August 28, 2026
First Posted
September 22, 2026
Study Start
September 30, 2026
Primary Completion (Estimated)
August 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
September 22, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share