Research on the Efficacy and Safety of Targeted Suprachiasmatic Nucleus Electrical Stimulation for Improving Metabolic Disorders in Patients With Stable Bipolar Disordercomorbid With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
研究概览
简要总结
This study aims to stabilize the patients with bipolar disorder (BD) comorbid with obesity in the stable phase by using temporal interference stimulation (TIS ) intervention. It intends to investigate the changes in key metabolic molecules such as GLP-1 circadian rhythm, and further explore the molecular mechanism of their metabolic disorders.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both biological parents are of Han ethnicity;
- •Age range: 18 to 45 years old, gender not restricted;
- •Meets the clinical diagnostic criteria for bipolar disorder as stipulated in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- •Body Mass Index (BMI) ≥ 28 kg/m2, or for males, waist circumference ≥ 90 cm and for females, waist circumference ≥ 85 cm;
- •HAMD-24 score < 7 points, YMRS score < 5 points;
- •All included researchers and their family members have given informed consent for this study.
排除标准
- •Individuals with other DSM-5 spectrum disorders;
- •Mental disorders caused by substance abuse (such as alcohol, drugs, etc.), and those with severe physical illnesses;
- •Those who consumed food or microecological preparations containing probiotics, prebiotics, etc. within one week before enrollment, and had a history of respiratory, urinary, digestive system infections and antibiotic use within one month before enrollment;
- •Those currently having serious suicidal thoughts or behaviors, or those with severe agitation;
- •Those who cannot follow medical advice for treatment, or those without guardians;
- •Pregnant or lactating women, or those planning to become pregnant;
- •Those who cannot complete MRI examinations due to special conditions such as having metal implants or pacemakers in their bodies.
研究组 & 干预措施
Temporal Interference Stimulation
TIS treatment lasts for 20 minutes, with the maximum output current being 2mA, which is adjusted according to the individual head model. The two pairs of electrical stimulation frequencies in tTIS are 1000Hz and 1040Hz.
干预措施: Temporal Interference Stimulation (Other)
Sham Temporal Interference Stimulation
The stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters werethe same as the Active Comparator arm.
干预措施: Sham Temporal Interference Stimulation Arm Description (Other)
研究者
Hu ShaoHua
Department of Psychaitry, The First Affiliated Hospital of Zhejiang University School of Medicine
First Affiliated Hospital of Zhejiang University