An interventional study of Continuous Theta Burst Stimulation (cTBS) and Intermittent Theta Burst Stimulation (iTBS) in Ischemic Stroke, sponsored by Ankara Etlik City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Ankara Etlik City Hospital · Not applicable, Interventional, and Treatment
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Ankara Etlik City Hospital is the lead sponsor of 176 studies on the registry; 77 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Device: Continuous Theta Burst Stimulation (cTBS) · Device: Intermittent Theta Burst Stimulation (iTBS)
Participants 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.
Device: Continuous Theta Burst Stimulation (cTBS) · Device: Sham Intermittent Theta Burst Stimulation
Participants 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.
Device: Intermittent Theta Burst Stimulation (iTBS) · Device: Sham Continuous Theta Burst Stimulation
Participants 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.
Device: Sham Continuous Theta Burst Stimulation · Device: Sham Intermittent Theta Burst Stimulation
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.
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
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 2, and Week 6
Change in Spasticity Assessed by the Modified Ashworth Scale
Spasticity of the upper and lower extremities will be assessed using the Modified Ashworth Scale (MAS). Scores range from 0 (no increase in muscle tone) to 4 (rigidity in flexion or extension), with six ordinal categories: 0, 1, 1+, 2, 3, and 4. Higher scores indicate greater muscle tone and resistance to passive movement, representing a worse outcome.
Time frame: Baseline, Week 2, and Week 6
Change in Sensory Function Assessed by the Fugl-Meyer Assessment - Sensory Subscale
Sensory function of the upper and lower extremities will be assessed using the sensory subsection of the Fugl-Meyer Assessment. This subsection evaluates light touch and joint position sense, with each item scored on a three-point ordinal scale (0-2). The combined sensory score for the upper and lower extremities ranges from 0 to 24, with higher scores indicating better sensory function.
Time frame: Baseline, Week 2, and Week 6
Change in Cortical Excitability Assessed by Motor Evoked Potential Amplitude
Cortical excitability will be evaluated by measuring motor evoked potential (MEP) amplitude.
Time frame: Baseline, Week 2, and Week 6
Change in Cortical Excitability Assessed by Motor Evoked Potential Latency
Cortical excitability will be evaluated by measuring motor evoked potential (MEP) latency.
Time frame: Baseline, Week 2, and Week 6
Change in Functional Ambulation Assessed by the Functional Ambulation Scale
Functional ambulation will be assessed using the Functional Ambulation Scale (FAS). The scale consists of six ordinal categories ranging from 0 to 5. A score of 0 indicates an inability to walk or the need for assistance from two or more people, whereas a score of 5 indicates independent walking on level and uneven surfaces, including stairs. Higher scores indicate greater independence in walking and a better functional outcome.
Time frame: Baseline, Week 2, and Week 6
Change in Independence in Activities of Daily Living Assessed by the Modified Barthel Index
Independence in activities of daily living and mobility will be assessed using the Modified Barthel Index. The index consists of 10 items, with item scores summed to yield a total score ranging from 0 to 100. A score of 0 indicates total dependence, whereas a score of 100 indicates independence in all assessed activities. Higher scores indicate greater functional independence and a better outcome.
Time frame: Baseline, Week 2, and Week 6
Change in Stroke-Specific Quality of Life
Stroke-specific quality of life will be assessed using the Turkish version of the Stroke-Specific Quality of Life Scale (SS-QOL). The scale consists of 48 items across eight domains. Each item is rated on a five-point scale ranging from 1 to 5. The mean item score will be calculated by averaging the scores of all 48 items, resulting in an overall score ranging from 1 to 5, with higher scores indicating better health-related quality of life.
Time frame: Baseline, Week 2, and Week 6
Plan to share: No
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