Investigating the Impact of ITBS Stimulation on Various Brain Regions on the HPA Axis in Stroke Patients Using Resting-State EEG Data.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Salivary Cortisol
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
Stimulation of the cerebellar group using iTBS.
In the trial, the group is anticipated to enroll 20 patients with post-stroke balance dysfunction for iTBS cerebellar stimulation.At the outset of enrollment (T0 phase), peripheral blood and saliva samples must be obtained to assess HPA axis-related indicators and to evaluate brain networks using TMS. Following the 15-day treatment period (T1 phase), the aforementioned blood samples will be collected once more for further testing. Furthermore, any adverse events will be documented, encompassing secondary cardiovascular events, epilepsy, and mortality outcomes.
干预措施: iTBS (Device)
Stimulation of the Left Dorsolateral Prefrontal Cortex group using iTBS.
In the trial, the group is anticipated to enroll 20 patients with post-stroke balance dysfunction for iTBS Left Dorsolateral Prefrontal Cortex stimulation.At the outset of enrollment (T0 phase), peripheral blood and saliva samples must be obtained to assess HPA axis-related indicators and to evaluate brain networks using TMS. Following the 15-day treatment period (T1 phase), the aforementioned blood samples will be collected once more for further testing. Furthermore, any adverse events will be documented, encompassing secondary cardiovascular events, epilepsy, and mortality outcomes.
干预措施: iTBS (Device)
Stimulation of the Primary Motor Cortex (M1) group using iTBS.
In the trial, the group is anticipated to enroll 20 patients with post-stroke balance dysfunction for iTBS Primary Motor Cortex stimulation.At the outset of enrollment (T0 phase), peripheral blood and saliva samples must be obtained to assess HPA axis-related indicators and to evaluate brain networks using TMS. Following the 15-day treatment period (T1 phase), the aforementioned blood samples will be collected once more for further testing. Furthermore, any adverse events will be documented, encompassing secondary cardiovascular events, epilepsy, and mortality outcomes.
干预措施: iTBS (Device)
结局指标
主要结局
Salivary Cortisol
时间窗: From the patient's first treatment to the completion of the 14-day iTBS therapy.
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).
Plasma adrenocorticotropic hormone
时间窗: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Plasma samples were collected from stroke patients in each group post-iTBS intervention. These samples were analyzed using ELISA to quantify ACTH levels in plasma. The aim was to explore the impact of iTBS stimulation on various brain regions on the HPA axis. The concentration of ACTH in plasma is measured in picograms per milliliter (pg/mL).
Plasma cortisol
时间窗: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Plasma samples were collected from stroke patients in each group post-iTBS intervention. These samples were analyzed using ELISA to quantify cortisol levels in plasma. The aim was to explore the impact of iTBS stimulation on various brain regions on the HPA axis. The concentration of cortisol in plasma is measured in nanograms per milliliter (ng/mL).
次要结局
- The National Institutes of Health Stroke Scale(From the patient's first treatment to the completion of the 14-day iTBS therapy.)
- The Modified Rankin Scale(From the patient's first treatment to the completion of the 14-day iTBS therapy.)
- Hamilton Anxiety Scale(From the patient's first treatment to the completion of the 14-day iTBS therapy.)
- Hamilton Depression Rating Scale(From the patient's first treatment to the completion of the 14-day iTBS therapy.)
- Self-Rating Depression Scale(From the patient's first treatment to the completion of the 14-day iTBS therapy.)
- Self-Rating Anxiety Scale(From the patient's first treatment to the completion of the 14-day iTBS therapy.)
研究者
Liqing Yao
Director, Department of Rehabilitation Medicine, the Second Affiliated Hospital of Kunming Medical University
The Second Affiliated Hospital of Kunming Medical University