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The application of transcranial cerebellar magnetic stimulation in the rehabilitation of Broca's aphasia after stroke and its brain network mechanism

The application of transcranial cerebellar magnetic stimulation in the rehabilitation of Broca's aphasia after stroke and its brain network mechanism

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125453
Enrollment
Unknown
Registered
2026-05-27
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Post-stroke aphasia

Interventions

Trial group:Conventional language rehabilitation training + true stimulation targeting the right cerebellum (cTBS mode, intramplexus frequency 50Hz, interplexus frequency 5Hz, intensity 80%, motor thr
Control group:Conventional language rehabilitation training + pseudo-stimulation targeting the right cerebellum (pseudo-stimulation pulses, parameters the same as those of the true stimulation group)
Observational group:None
Normal control group:None

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion Criteria for BA Patients (1) Aged 18 to 80 years (inclusive), with an education level of primary school or above; (2) Native speaker of Standard Mandarin, right-handed, with no family history of left-handedness; (3) Disease duration between 14 and 60 days, with language impairment as the primary symptom at onset; (4) For the second part of the study, patients with contraindications to TMS are excluded; (5) First-ever stroke, confirmed by CT/MRI, with a single lesion located in the left cerebral hemisphere; (6) Diagnosed as BA according to the Western Aphasia Battery; cognitive function assessed using the Loewenstein Occupational Therapy Cognitive Assessment (LOTCA), excluding patients with aphasia combined with severe non-linguistic cognitive impairment; (7) Able to cooperate in completing neuropsychological assessments and imaging examinations; (8) Signed informed consent form. 2. Inclusion Criteria for HC (Healthy Controls) (1) Education level of primary school or above; (2) No history of cerebrovascular disease, traumatic brain injury, epilepsy, dementia, or other neurological disorders; (3) Normal function of heart, lungs, liver, kidneys, and other organs; (4) No visual field defects or peripheral hearing impairments; (5) Normal language function assessed by the Western Aphasia Battery (Aphasia Quotient > 93.8) and normal cognitive function assessed by the Montreal Cognitive Assessment (MoCA) (total score = 26); (6) No contraindications for MRI examination; no abnormalities detected on MRI; (7) Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for BA patients: (1) Pre-existing language impairment before the current onset, or language impairment caused by other reasons: history of transient ischemic attack; stroke caused by conditions related to cognitive impairment, such as moyamoya disease or amyloid angiopathy; (2) History of psychiatric disorders such as schizophrenia; patients with contraindications to TMS are excluded in the second part of the study; (3) Severe cardiac, hepatic, or renal insufficiency; (4) Visual field defects or peripheral hearing impairment; (5) History of craniotomy or previous epileptic seizures; severe dysarthria; consciousness disorder with Glasgow Coma Scale score of 15 points; (6) Imaging findings of cerebral small vessel disease, such as white matter lesions, microbleeds, enlarged perivascular spaces, or brain atrophy; (7) Comorbid depressive state after the current onset (Hospital Version of the Stroke Aphasic Depression Questionnaire, 10th edition, score >6); (8) Recurrent stroke or new intracranial lesions (such as space-occupying lesions) during the study; (9) Signed informed consent form; (10) Unable to complete TMS treatment; (11) Obvious head movement during magnetic resonance scanning (>3 mm), affecting image quality; (12) Unable to complete follow-up; (13) The patient voluntarily requests withdrawal from the study. 2. Exclusion criteria for HC: (1) History of stroke, intracranial space-occupying lesions, or other diseases; (2) History of definite psychiatric disorders such as schizophrenia, or comorbid depressive state.

Design outcomes

Primary

MeasureTime frame
Word Fluency Test,WFT;West Aphasia Battery,WAB;Phoneme-level test;Vocabulary-level test;Grammar-level test (sentence production);Boston Diagnostic Aphasia Examination,BDAE;Resting state functional nuclear magnetic related indicators;Edinburgh Handedness Inventory;Chinese Aphasia Fluency Characteristics Scale;

Secondary

MeasureTime frame
Instrumental Activities of Daily Living Scale, IADL;Stroke and Aphasia Quality of Life Scale, SAQOL-39g;Loewenstein Occupational Therapy Cognitive Assessment,LOTCA;Stroke Aphasic Depression Questionnaire Hospital Version,SADQ-H;

Countries

China

Contacts

Public ContactZhang Yumei

Beijing Tiantan Hospital, Capital Medical University

zhangyumei95@aliyun.com+86 136 9140 4106

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 12, 2026