Effectiveness of Theta Burst Stimulation For Upper and Lower Extremity Recovery in Stroke
ConditionIschemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorAnkara Etlik City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
History of epilepsy.
Presence of a pacemaker.
Pregnancy.
Neurological disease other than stroke.
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous Theta Burst Stimulation (cTBS)
DeviceContinuous 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)
DeviceIntermittent 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
DeviceSham 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
DeviceSham intermittent theta burst stimulation will be delivered over the ipsilesional primary motor cortex using a sham coil for approximately 190 seconds.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Coupled TBS GroupExperimental treatment 2 interventions
Group B: cTBS + Sham iTBS GroupExperimental treatment 2 interventions
Group C: Sham cTBS + iTBS GroupExperimental treatment 2 interventions
Group D: Sham TBS GroupSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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 62
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 63
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 6Secondary outcomes
1
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 62
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 63
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 64
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 6Sponsors and contacts
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Source ClinicalTrials.gov