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Ischemic StrokeNCT07834333

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

A study testing Continuous Theta Burst Stimulation (cTBS) and Intermittent Theta Burst Stimulation (iTBS) in people with Ischemic Stroke, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
Continuous Theta Burst Stimulation (cTBS) and Intermittent Theta Burst Stimulation (iTBS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Sep 2026to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fatma Melis Ertuğrul Öztürk, Resident contact

03127970000

melis.ertugrul@hotmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Ankara Etlik Şehir Hastanesi

    Ankara, Yenimahalle, 06170

    Fatma Melis Ertuğrul Öztürk, Resident, 03127970000, melis.ertugrul@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Conditions
Ischemic Stroke
Being tested
Continuous Theta Burst Stimulation (cTBS), Intermittent Theta Burst Stimulation (iTBS), Sham Continuous Theta Burst Stimulation, Sham Intermittent Theta Burst Stimulation
Keywords
Theta Burst Stimulation, Stroke Rehabilitation, Motor Recovery, Upper Extremity Motor Function, Lower Extremity Motor Function, Cortical Excitability, Transcranial Magnetic Stimulation
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 StimulationDevice

    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 StimulationDevice

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

Study groups in NCT07834333
Study groupRoleWhat they receive
Coupled TBS GroupExperimentalParticipants 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.
Receives: Device: Continuous Theta Burst Stimulation (cTBS); Device: Intermittent Theta Burst Stimulation (iTBS)
cTBS + Sham iTBS GroupExperimentalParticipants 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.
Receives: Device: Continuous Theta Burst Stimulation (cTBS); Device: Sham Intermittent Theta Burst Stimulation
Sham cTBS + iTBS GroupExperimentalParticipants 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.
Receives: Device: Intermittent Theta Burst Stimulation (iTBS); Device: Sham Continuous Theta Burst Stimulation
Sham TBS GroupSham 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.
Receives: Device: Sham Continuous Theta Burst Stimulation; Device: Sham Intermittent Theta Burst Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, Week 2, and Week 6

  2. 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.

    Measured: Baseline, Week 2, and Week 6

  3. 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.

    Measured: Baseline, Week 2, and Week 6

Secondary outcomes (7)
  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.

    Measured: Baseline, Week 2, and Week 6

  2. 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.

    Measured: Baseline, Week 2, and Week 6

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

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

    Measured: Baseline, Week 2, and Week 6

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

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

    Measured: Baseline, Week 2, and Week 6

  5. 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.

    Measured: Baseline, Week 2, and Week 6

  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.

    Measured: Baseline, Week 2, and Week 6

  7. 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.

    Measured: Baseline, Week 2, and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2026
  2. Study start30 Sep 2026
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07834333
Sponsor's protocol ID
AEŞH-2025-070
Status last verified
Nov 2026
First submitted
28 Aug 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29439359
  • Kuzu 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.

    PubMed 33887662
  • Chen 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.

    PubMed 33361618
  • Fu 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.

    PubMed 39609900
  • Meng 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.

    PubMed 32039879

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Theta Burst Stimulation (cTBS) and Intermittent Theta Burst Stimulation (iTBS) in people with Ischemic Stroke, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fatma Melis Ertuğrul Öztürk, Resident (03127970000, melis.ertugrul@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07834333, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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