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A study of precise targeted burst transcranial stimulation in the treatment of subcortical post-stroke aphasia

A study of precise targeted burst transcranial stimulation in the treatment of subcortical post-stroke aphasia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113367
Enrollment
Unknown
Registered
2025-11-27
Start date
2025-11-30
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Stroke

Interventions

Experimental Group:Based on the exclusion of ineffective regions by resting-state fMRI and DTI, parameters :90%RUT, intra-plexus frequency 50Hz, 3 intra-plexus pulses, inter-plexus frequency 5Hz
Dosage and treatment course: Once a day. Each treatment session consists of an intraplexus frequency of 50Hz, 3 intraplexus pulses, an interplexus frequency of 5Hz, 10 intraplexus pulses, repeated 20
Control group:parameters: 90% RUT, intraplex frequency 50Hz, 3 intraplex pulses, interplexic frequency 5Hz
Dosage and duration: Once a day, each treatment is intraplexic frequency 50Hz, intraplexic pulse 3, interplexic frequency 5Hz, intraplexic number 10, 20 repetitions, intermediate 8s, total pulse 600,

Sponsors

China Rehabilitation Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.The patient is 45 years old or above (including 45 years old). 2. Meet the diagnostic criteria for Acute ischemic stroke (using the Guidelines for the Early Management of Patients With Acute written by the American Heart Association/American Stroke Association in 2019 Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke and the Neurology Branch of the Chinese Medical Association in 2018 The diagnosis was made in accordance with the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018". The lesions were all in the left hemisphere, and the disease course was greater than or equal to 3 months and less than or equal to 1 year. 3. According to the Chinese version of the Western Aphasia Checklist (WAB), the patient was assessed as having aphasia, with an WAB aphasia quotient of less than 93.8 points. 4. First onset, or previous onset without obvious sequelae (modified Rankin Scale (mRS) score before this stroke <=1 point); 5. Before the onset of the disease, the language function was normal, and the native language was Chinese, with a primary school education or above (having received more than 6 years of education). 6. Understand the trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those with severe articulation disorders (NIHSS articulation item 10 >=2 points); 2. Aphasia caused by other diseases such as brain tumors, Parkinson's syndrome, motor neuron disease, cerebral hemorrhage, and brain trauma; 3. Individuals with cardiac pacemakers, cochlear implants or other metal foreign bodies, or any electronic devices implanted in the body, those with claustrophobia or other contraindications for MRI scans, and those with contraindications for TMS treatment; 4. History of epilepsy (at least two non-induced epileptic seizures with an interval of more than 24 hours, or diagnosed with epilepsy syndrome, or having epileptic seizures within the past 12 months); 5. Patients who have been found to have severe systemic diseases such as heart, lung, liver and kidney through laboratory tests and examinations and whose conditions cannot be controlled by conventional medication; 6. Patients with combined consciousness disorders (NIHSS item 1(a) >=1 point); 7. Combined with malignant hypertension (sudden and significant increase in blood pressure, with both systolic and diastolic blood pressures elevated, often remaining above 200/130 MMHG); 8. Patients with concurrent malignant tumors; 9. Patients whose life expectancy is less than one year due to reasons other than stroke; 10. Those with combined deafness, visual impairment, severe cognitive impairment, etc., to the extent that they are unable to cooperate with the experiment; 11. Patients who are in a state of severe depression or anxiety, or have been diagnosed with other mental disorders that prevent them from cooperating to complete the trial; 12. Those who have received other neuroregulation treatments such as TMS and transcranial electrical stimulation in the 3 months prior to enrollment; 13. There is a history of concurrent alcohol abuse, drug abuse, etc. 14. Patients who have other abnormal examination results and are judged by the researchers as unsuitable for participating in this trial; 15. Women of childbearing age who are pregnant or planning to become pregnant; 16. Those who are participating in other clinical research trials.

Design outcomes

Primary

MeasureTime frame
Western Aphasia Test;Changes in brain functional and structural connections before and after treatment;

Countries

China

Contacts

Public ContactWang Xiaoyi;Zhang Xiaonian

China Rehabilitation Research Center

youthzxn@163.com+86 136 5137 6101

Outcome results

None listed

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