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An Exploratory Study of the Therapeutic Effects and Mechanisms of cTBS Stimulation on the Cerebellum in Patients with Post-Stroke Non-fluent Aphasia

An Exploratory Study of the Therapeutic Effects and Mechanisms of cTBS Stimulation on the Cerebellum in Patients with Post-Stroke Non-fluent Aphasia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105252
Enrollment
Unknown
Registered
2025-07-01
Start date
2025-07-09
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

Post-stroke Aphasia

Interventions

Cerebellar Stimulation Group:The combination therapy of cTBS on right cerebellum and SLT
Cerebral Stimulation Group:The combination therapy of cTBS on right cerebral hemisphere and SLT
Sham Stimulation Group:The combination therapy of sham cTBS on right cerebellum and SLT

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 75 years; (2) Meet the diagnostic criteria for ischemic stroke (according to the 2018 guidelines of the Chinese Society of Neurology) or meet the diagnostic criteria for hemorrhagic stroke (according to the 2019 guidelines of the Chinese Society of Neurology); first-ever stroke occurrence; lesions located in the left hemisphere; disease duration =15 days and =6 months. (3) Non-fluent aphasia (speech fluency score: 0–4) diagnosed using the Chinese version of the Western Aphasia Battery with an Aphasia Quotient (AQ) <93.8; (4) Right-handed assessed by the Edinburgh Handedness Inventory; (5) Native Mandarin speakers with intact pre-stroke language function, had=6 years of formal education; (6) Written informed consent from all subjects who participated in the study.

Exclusion criteria

Exclusion criteria: (1) A lesion in the right cerebellum or the right cerebral hemisphere; (2) Complicated by any neuropsychiatric diseases, such as Parkinson's disease or dementia; (3) Inability to cooperate due to dysarthria (NIHSS 10 >= 2) , severe hearing impairment, visual impairment, cognitive impairment or altered consciousness (NIHSS 1a >= 1); (4) Complicated by severe cardiac, pulmonary, hepatic, or renal dysfunction, or other major systemic diseases; (5) Medications altering the level of cortical excitability (e.g., antiepileptics, neuroleptics or benzodiazepines); (6) Patients with severe depression, anxiety, or other mental illnesses that preclude trial compliance; (7) Contraindications for rTMS according to the safety guide-lines: presence of metallic foreign bodies or implanted electronic devices; (8) Any neuromodulation treatment (including TMS or tDCS) in the 3 months before enrollment; (9) History of alcohol or drug abuse, or other abnormalities rendering the patient unsuitable for the trial as assessed by investigators; (10) Female participants who are pregnant, lactating, or of reproductive age with intentions or potential for pregnancy during the study; (11) Concurrent enrollment in any other interventional study.

Design outcomes

Primary

MeasureTime frame
Western Aphasia Battery;Resting-state functional magnetic resonance imaging data;

Secondary

MeasureTime frame
Boston Diagnostic Aphasia Examination Severity Rating;Token test;Stroke and Aphasia Quality of Life Scale-39 generic version;

Countries

China

Contacts

Public ContactWang Qiang

The Affiliated Hospital of Qingdao University

guangtao217@163.com+86 186 6180 6021

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026