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.

Launched by THE SECOND AFFILIATED HOSPITAL OF KUNMING MEDICAL UNIVERSITY · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called intermittent Theta Burst Stimulation (iTBS) to see how it affects feelings of anxiety and depression in people who have had a stroke. The researchers will divide stroke patients into three groups, with each group receiving iTBS targeting different parts of the brain: the cerebellum, the dorsolateral prefrontal cortex, and the primary motor cortex. Each group will include 20 participants, and the study will measure changes in mood, anxiety levels, and brain activity before and after the treatment. They will also collect samples of blood and saliva to analyze hormone levels related to stress.

To be eligible for this trial, participants should be between 18 and 85 years old, have experienced a stroke within the last 6 months or longer ago, and have certain brain injury characteristics. They should also be able to cooperate with the study and not have severe mental health issues or other serious health conditions. If you or someone you know is interested, please be aware that this trial is not yet recruiting participants, but it aims to provide important insights into improving emotional well-being after a stroke.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Initial stroke onset \<6 months, or the last stroke event occurred more than 6 months ago;
• • 2. Age ≥18 years, \<85 years (the likelihood of VCI increases beyond 85 years);
• • 3. Patients with lesions in the middle cerebral artery region;
• • 4. NIHSS \>4, NIHSS \<26;
• • 5. mRS score ≥2;
• • 6. Completion of CT or MRI;
• • 7. No severe neurological or psychiatric disorders; no impairment of consciousness, able to cooperate with relevant treatments; no severe cognitive impairment (MMSE ≥15);
• • 8. All participants are right-handed;
• • 9. Signed informed consent form.
• Exclusion Criteria:
• • 1. History of epilepsy or psychiatric disorders (including depression, anxiety, or schizophrenia);
• • 2. Severe comorbidities;
• • 3. History of medication use: benzodiazepines, baclofen, or antidepressants;
• • 4. Non-compliance with the protocol;
• • 5. Acute phase of cerebral hemorrhage or acute infectious diseases;
• • 6. Severe suicidal tendencies in patients with depression;
• • 7. Severe headache, hypertension, malignant tumors, open wounds, vascular embolism, leukopenia, or other serious conditions;
• • 8. Severe alcohol abuse;
• • 9. History of cranial surgery or presence of metal implants in the brain;
• • 10. Patients with cardiac pacemakers;
• • 11. NIHSS \> 26 or MMSE \< 15;
• • 12. Any condition likely to result in the patient's survival for less than 1 month;
• • 13. Pregnancy.