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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying how a type of brain stimulation called intermittent Theta Burst Stimulation affects stress hormones like cortisol and ACTH in people with post-stroke depression — can you explain how measuring these hormones would help us understand whether the treatment is actually working on my mood?
2Since this trial is listed as 'not yet recruiting,' do you have a sense of when it might open, and would waiting to potentially join it affect my current treatment for post-stroke depression in the meantime?
3This study targets different brain regions with the stimulation — given my specific stroke location and symptoms, would you consider any of those brain regions particularly relevant or risky for me to have stimulated?
4This trial is listed as Phase NA, which I understand might mean it's more focused on understanding how the treatment works rather than proving it's effective — does that mean there's less known about the safety profile, and what should I know about the risks of brain stimulation at this stage?
5Are there standard treatments for post-stroke depression, like antidepressants or conventional therapy, that I should consider trying first while this trial is still in the early stages and not yet open to patients?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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