Effects of Intermittent Theta-Burst Stimulation (iTBS) combined with Task Oriented Training (TOT) for improving Upper Limb Function following Sub-acute Stroke: A Randomized Controlled Trial

Status

Unknown

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20241215013

Enrollment

Registered

2024-12-15

Start date

2024-12-10

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegic stroke patients with ischemic or hemorrhagic stroke Stroke, Cerebrovascular accident, Intermittent theta-burst stimulation (iTBS), Task-oriented training (TOT), Upper limb, Motor function

Interventions

Group A (iTBS + TOT) comprises participants who will undergo intermittent theta-burst stimulation plus task-oriented training. Treatment Duration: iTBS for 3 minutes and TOT for 45 minutes.,Group B (i

Experimental Device,Sham Comparator Device,Active Comparator Other

Intermittent Theta-Burst Stimulation + Task-Oriented Training,Sham Intermittent Theta-Burst Stimulation + Task-Oriented Training,Regular Rehabilitation

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. First-ever unilateral ischemic or hemorrhagic stroke in the territory of the middle cerebral artery documented by computed tomography (CT) or magnetic resonance imaging (MRI). 2. Patients who will present within 1 month and 6 months post-stroke will be enrolled. 3. Age 18-80 years 4. Both genders (i.e., male and female) 5. A National Institute of Health Stroke Scale (NIHSS) of 1 to 15 points at enrollment (Vanacker et al., 2016). 6. Ability to provide written informed consent and comprehend instructions.

Exclusion criteria

Exclusion criteria: 1. A large area of cerebral infarct or hemorrhage in the frontal or temporal lobe. 2. Major circulatory, respiratory disease, pregnancy, neurological disease/deficit other than stroke. 3. Severe limb orthopedic conditions. 4. Malignancy 5. Recent use of drugs that alter cortical excitability (e.g., sedatives, antidepressants) 6. History of seizure attack, dementia, cognitive impairment, or other neurodegenerative diseases. 7. Any contraindication to TMS or MRI (e.g., pacemakers in the heart or metallic objects in the head).

Design outcomes

Primary

Measure	Time frame
Motor function 4 week Fugl-Meyer Assessment Scale for Upper Extremity, Modified Barthel Index, National Institute of Health and Stroke Severity Scale	—

Secondary

Measure	Time frame
Motor function 4 week Fugl-Meyer Assessment Scale for Upper Extremity, Modified Barthel Index, National Institute of Health and Stroke Severity Scale	—

Countries

China

Contacts

Public ContactRida Fatima

Chongqing Medical University

ridadoctor345@gmail.com18716531052

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026