NCT06899893Not yet recruiting
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.
Investigating the Impact of ITBS Stimulation on Various Brain Regions on the HPA Axis in Stroke Patients Using Resting-State EEG Data.
Source: ClinicalTrials.gov · Last updated 28 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 10 Mar 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical University
- Diseases
- Stroke
- NCT number
- NCT06899893
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Apr 2025 to the primary completion date, 30 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of epilepsy or psychiatric disorders (including depression, anxiety, or schizophrenia);
- History of medication use: benzodiazepines, baclofen, or antidepressants;
- Acute phase of cerebral hemorrhage or acute infectious diseases;
- Severe headache, hypertension, malignant tumors, open wounds, vascular embolism, leukopenia, or other serious conditions;
- History of cranial surgery or presence of metal implants in the brain;
- Patients with cardiac pacemakers;
- Any condition likely to result in the patient's survival for less than 1 month;
Other
- Severe comorbidities;
- Non-compliance with the protocol;
- Severe suicidal tendencies in patients with depression;
- Severe alcohol abuse;
- NIHSS \> 26 or MMSE \< 15;
- Pregnancy.
Who the study is looking for
- 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;
- Signed informed consent form.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.