Clinical trial NCT06899893: 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.
Official title: Investigating the Impact of ITBS Stimulation on Various Brain Regions on the HPA Axis in Stroke Patients Using Resting-State EEG Data.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Post-stroke Depression
Lead sponsor: The Second Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 primary motor cortex (M1), with 20 patients allocated to each group. Neurofunctional scores, anxiety and depression assessments, and transcranial magnetic stimulation evoked potentials (TEP) will be assessed pre- and post-treatment within each group. The relationship between anxiety and depression scores and brain network characteristics associated with emotions will be examined to investigate the impact of iTBS stimulation on post-stroke negative emotions. Furthermore, plasma and saliva samples will be collected from stroke patients in each group post iTBS intervention. ELISA will quantify ACTH levels in plasma and cortisol levels in both plasma and saliva, with the aim of exploring the effects of iTBS stimulation on the HPA axis across different brain regions.


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.

Primary outcomes:
measure: Salivary Cortisol
timeFrame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
measure: Plasma adrenocorticotropic hormone
timeFrame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
measure: Plasma cortisol
timeFrame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Secondary outcomes:
measure: The National Institutes of Health Stroke Scale
timeFrame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
measure: The Modified Rankin Scale
timeFrame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
measure: Hamilton Anxiety Scale
timeFrame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
measure: Hamilton Depression Rating Scale
timeFrame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
measure: Self-Rating Depression Scale
timeFrame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
measure: Self-Rating Anxiety Scale
timeFrame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Other outcomes:
Locations:
Study officials:
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