Status:
NOT_YET_RECRUITING
The Research Team Aims to Elucidate the Impact of ITBS (intermittent Theta Burst Stimulation) on the HPA Axis and Post-stroke Negative Emotions/depression by Conducting Human Experiments That Target Various Brain Regions.
Lead Sponsor:
The Second Affiliated Hospital of Kunming Medical University
Conditions:
Stroke
Post-stroke Depression
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The project team will categorize stroke patients into three groups receiving iTBS stimulation targeting distinct brain regions: the cerebellum, the dorsolateral prefrontal cortex (DLPFC), and the prim...
Eligibility Criteria
Inclusion
- Initial stroke onset \<6 months, or the last stroke event occurred more than 6 months ago;
- Age ≥18 years, \<85 years (the likelihood of VCI increases beyond 85 years);
- Patients with lesions in the middle cerebral artery region;
- NIHSS \>4, NIHSS \<26;
- mRS score ≥2;
- Completion of CT or MRI;
- No severe neurological or psychiatric disorders; no impairment of consciousness, able to cooperate with relevant treatments; no severe cognitive impairment (MMSE ≥15);
- All participants are right-handed;
- Signed informed consent form.
Exclusion
- History of epilepsy or psychiatric disorders (including depression, anxiety, or schizophrenia);
- Severe comorbidities;
- History of medication use: benzodiazepines, baclofen, or antidepressants;
- Non-compliance with the protocol;
- Acute phase of cerebral hemorrhage or acute infectious diseases;
- Severe suicidal tendencies in patients with depression;
- Severe headache, hypertension, malignant tumors, open wounds, vascular embolism, leukopenia, or other serious conditions;
- Severe alcohol abuse;
- History of cranial surgery or presence of metal implants in the brain;
- Patients with cardiac pacemakers;
- NIHSS \> 26 or MMSE \< 15;
- Any condition likely to result in the patient's survival for less than 1 month;
- Pregnancy.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06899893
Start Date
April 1 2025
End Date
July 30 2027
Last Update
March 28 2025
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