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.

Официальное название

Investigating the Impact of ITBS Stimulation on Various Brain Regions on the HPA Axis in Stroke Patients Using Resting-State EEG Data.

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Salivary Cortisol [Срок оценки: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
• Plasma adrenocorticotropic hormone [Срок оценки: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
• Plasma cortisol [Срок оценки: From the patient's first treatment to the completion of the 14-day iTBS therapy.]

Вторичные конечные точки (6)

• The National Institutes of Health Stroke Scale [Срок оценки: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
• The Modified Rankin Scale [Срок оценки: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
• Hamilton Anxiety Scale [Срок оценки: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
• Hamilton Depression Rating Scale [Срок оценки: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
• Self-Rating Depression Scale [Срок оценки: From the patient's first treatment to the completion of the 14-day iTBS therapy.]
• Self-Rating Anxiety Scale [Срок оценки: From the patient's first treatment to the completion of the 14-day iTBS therapy.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06899893 · Shen-PJ-Ke-2025-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗