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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: iTBS.
- Who it may be relevant to
- Registry conditions: Stroke, Post-stroke Depression. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigating the Impact of ITBS Stimulation on Various Brain Regions on the HPA Axis in Stroke Patients Using Resting-State EEG Data.
Overview
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.
Interventions
- Device iTBS
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 st
Primary outcome measures
- Salivary Cortisol [Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
- Plasma adrenocorticotropic hormone [Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
- Plasma cortisol [Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
Secondary outcome measures (6)
- The National Institutes of Health Stroke Scale [Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
- The Modified Rankin Scale [Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
- Hamilton Anxiety Scale [Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
- Hamilton Depression Rating Scale [Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
- Self-Rating Depression Scale [Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
- Self-Rating Anxiety Scale [Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
Eligibility criteria
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;
- Signed informed consent form.
Exclusion criteria
- 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;
- Acute phase of cerebral hemorrhage or acute infectious diseases;
- Severe suicidal tendencies in patients with depression;
- Severe headache, hypertension, malignant tumors, open wounds, vascular embolism, leukopenia, or other serious conditions;
- Severe alcohol abuse;
- History of cranial surgery or presence of metal implants in the brain;
- Patients with cardiac pacemakers;
- NIHSS > 26 or MMSE < 15;
- Any condition likely to result in the patient's survival for less than 1 month;
- Pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06899893 · Shen-PJ-Ke-2025-1