The Research Team Aims to Elucidate the Impact of ITBS (intermittent Theta Burst Stimulation) on … (NCT06899893) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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.
60 participantsStarted 2025-04-01
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. History of epilepsy or psychiatric disorders (including depression, anxiety, or schizophrenia);
✕. Severe comorbidities;
What they're measuring
1
Salivary Cortisol
Timeframe: From the patient's first treatment to the completion of the 14-day iTBS therapy.
2
Plasma adrenocorticotropic hormone
Timeframe: From the patient's first treatment to the completion of the 14-day iTBS therapy.
3
Plasma cortisol
Timeframe: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Trial details
NCT IDNCT06899893
SponsorThe Second Affiliated Hospital of Kunming Medical University