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.

Kunming Medical University

Status: Not yet enrolling

Conditions: Stroke; Post-stroke Depression

Treatments: Device: iTBS

Study type: Interventional

Funder types: Other

Identifiers

NCT06899893

Shen-PJ-Ke-2025-1

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Stimulation of the cerebellar group using iTBS.

Experimental group

Description:

In the trial, the group is anticipated to enroll 20 patients with post-stroke balance dysfunction for iTBS cerebellar stimulation.At the outset of enrollment (T0 phase), peripheral blood and saliva samples must be obtained to assess HPA axis-related indicators and to evaluate brain networks using TMS. Following the 15-day treatment period (T1 phase), the aforementioned blood samples will be collected once more for further testing. Furthermore, any adverse events will be documented, encompassing secondary cardiovascular events, epilepsy, and mortality outcomes.

Treatment:

Device: iTBS

Stimulation of the Left Dorsolateral Prefrontal Cortex group using iTBS.

Experimental group

Description:

In the trial, the group is anticipated to enroll 20 patients with post-stroke balance dysfunction for iTBS Left Dorsolateral Prefrontal Cortex stimulation.At the outset of enrollment (T0 phase), peripheral blood and saliva samples must be obtained to assess HPA axis-related indicators and to evaluate brain networks using TMS. Following the 15-day treatment period (T1 phase), the aforementioned blood samples will be collected once more for further testing. Furthermore, any adverse events will be documented, encompassing secondary cardiovascular events, epilepsy, and mortality outcomes.

Treatment:

Device: iTBS

Stimulation of the Primary Motor Cortex (M1) group using iTBS.

Experimental group

Description:

In the trial, the group is anticipated to enroll 20 patients with post-stroke balance dysfunction for iTBS Primary Motor Cortex stimulation.At the outset of enrollment (T0 phase), peripheral blood and saliva samples must be obtained to assess HPA axis-related indicators and to evaluate brain networks using TMS. Following the 15-day treatment period (T1 phase), the aforementioned blood samples will be collected once more for further testing. Furthermore, any adverse events will be documented, encompassing secondary cardiovascular events, epilepsy, and mortality outcomes.

Treatment:

Device: iTBS