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.

ConditionsStroke Post-stroke Depression

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-85

SponsorThe Second Affiliated Hospital of Kunming Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

iTBS
Device
Sixty patients experiencing post-stroke negative emotions were recruited and categorized into groups based on their conditions. The group with post-stroke balance dysfunction underwent intermittent theta burst stimulation (iTBS) of the cerebellum, while the group with post-stroke cognitive dysfunction received iTBS stimulation of the left dorsolateral prefrontal cortex (DLPFC), and the group with post-stroke motor dysfunction underwent iTBS stimulation of the primary motor cortex (M1).The TMS stimulation protocol consisted of 20-minute sessions, five times a week, for a total of ten sessions, utilizing a figure-of-eight coil (model B9076, coil diameter 92 mm, manufactured by Yiruide Company in Wuhan, China, transcranial magnetic therapy device model NS5000). The stimulation intensity was set at 80% of the active motor threshold, with the coil positioned tangentially to the scalp and the handle oriented upwards.

Treatment groups

60 Participants

are divided into 3 treatment groups

Group A: Stimulation of the cerebellar group using iTBS.Experimental treatment 1 intervention

Group B: Stimulation of the Left Dorsolateral Prefrontal Cortex group using iTBS.Experimental treatment 1 intervention

Group C: Stimulation of the Primary Motor Cortex (M1) group using iTBS.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Salivary Cortisol

Saliva samples were collected from stroke patients in each group post-iTBS intervention. These samples were analyzed using ELISA to quantify cortisol levels in saliva. The aim was to explore the impact of iTBS stimulation on various brain regions on the HPA axis. The concentration of cortisol in saliva is measured in nanograms per milliliter (ng/mL).

Time frame