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NCT Number: NCT07834333

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik Şehir Hastanesi

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location status: Recruiting

Location contact

Fatma Melis Ertuğrul Öztürk, Resident

CONTACT

[email protected]

03127970000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment - Upper Extremity Motor Subscale (FMA-UE)

    Time frame: Baseline, Week 2, and Week 6

    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

  2. Change in Lower Extremity Motor Function Assessed by the Fugl-Meyer Assessment - Lower Extremity Motor Subscale

    Time frame: Baseline, Week 2, and Week 6

    Lower extremity motor recovery will be assessed using the lower extremity motor subsection of the Fugl-Meyer Assessment.

  3. Change in Motor Recovery Stage Assessed by the Brunnstrom Motor Recovery Stages

    Time frame: Baseline, Week 2, and Week 6

    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.

Secondary outcomes

  1. Change in Spasticity Assessed by the Modified Ashworth Scale

    Time frame: Baseline, Week 2, and Week 6

    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.

  2. Change in Sensory Function Assessed by the Fugl-Meyer Assessment - Sensory Subscale

    Time frame: Baseline, Week 2, and Week 6

    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.

  3. Change in Cortical Excitability Assessed by Motor Evoked Potential Amplitude

    Time frame: Baseline, Week 2, and Week 6

    Cortical excitability will be evaluated by measuring motor evoked potential (MEP) amplitude.

  4. Change in Cortical Excitability Assessed by Motor Evoked Potential Latency

    Time frame: Baseline, Week 2, and Week 6

    Cortical excitability will be evaluated by measuring motor evoked potential (MEP) latency.

  5. Change in Functional Ambulation Assessed by the Functional Ambulation Scale

    Time frame: Baseline, Week 2, and Week 6

    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.

  6. Change in Independence in Activities of Daily Living Assessed by the Modified Barthel Index

    Time frame: Baseline, Week 2, and Week 6

    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.

  7. Change in Stroke-Specific Quality of Life

    Time frame: Baseline, Week 2, and Week 6

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma Melis Ertuğrul Öztürk, Resident

CONTACT

[email protected]

03127970000

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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