Effect of Transcranial Alternating Current Stimulation (tACS) on Serotonin-1A Receptor in Patients With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The changes in quantitative MPPF values before and after the tACS intervention.
研究概览
简要总结
This study will apply a comprehensive tools that integrates neuroimaging, psychological evaluation, and sleep monitoring through 18F-MPPF PET/MR, neuropsychological tests, and polysomnography (PSG) to explore the neurobiological mechanisms underlying transcranial alternating current stimulation (tACS) for depressive disorders, mainly focusing on the serotonergic system revealed by Serotonin-1A (5-HT1A) receptor.
详细描述
5-HT1A receptor appears to be significantly involved in the effectiveness of electroconvulsive therapy (ECT). Like alternating current in ECT, tACS also applies alternating current to intervene in neuropsychiatric disorders. We previously found that tACS with large current, such as 15 mA, via the forehead and bilateral mastoids can improve depressive symptoms. However, the underlying mechanism of 15 mA tACS in depression remains unclear. We propose a scientific hypothesis that 15 mA tACS may increase hippocampal 5- HT1A receptors, then to reduce depression in depressive patients. Meanwhile, 15 mA tACS may increase the whole-brain functional connectivity with the hippocampus as the seed point. This study will utilize a multimodal data through 18F-MPPF PET/MR, including MPPF metabolism, resting-state fMRI, DTI, and 3D-T1 structural images. By observing the alterations of 5-HT1A receptor and the functional network between MDD patients and healthy controls, and between the pre- and post-tACS intervention in MDD patients, our aims to explore the effect of tACS on the serotonergic system in depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusive Criteria:
- •18 to 65 years old, Chinese, male or female.
- •Non-psychotic major depressive disorder according to DSM-IV.
- •HAMD-17 total score ≥ 17 at the baseline.
- •Currently experiencing an acute episode.
- •No history of prior treatment with psychotropic medications.
- •Understanding of all aspects of the research protocol and the ability to provide informed consent.
排除标准
- •for patients:
- •Unable to do PET/MR examinations.
- •Have secondary insomnia disorders, anxiety disorders, or depressive disorders caused by physical illnesses.
- •Severe or unstable organic diseases.
- •Pregnant or lactating women or those planning a pregnancy in the near future.
- •Alcohol or substance dependence or abuse within the past year.
- •Received electroconvulsive therapy or transcranial magnetic stimulation in the month preceding enrollment.
- •Skin damage at the electrode placement site or those allergic to electrode gel or adhesives.
- •Participated in any other clinical trials within the month before baseline.
- •Any inappropriate conditions considered by the study group.
- •Inclusion Criteria for healthy volunteers
- •To undergo PET/MR examinations.
- •Be matched with the patient group regarding age, sex, and educational level.
- •Exclusion Criteria for healthy volunteers:
- •Those who are enrolled in other clinical studies.
- •The inappropriate conditions considered by the study group.
研究组 & 干预措施
Depressive disorders
Three conductive electrodes will be placed overhead. Based on the 10/20 international placement system, a 4.45 x 9.53 cm electrode is placed on the forehead corresponding to Fpz, Fp1 and Fp2. Two 3.18 x 3.81 cm electrodes are placed on the mastoid region of each side.
The tACS stimulation waveform includes ramp-up and ramp-down periods of 180 and 12 s, respectively. It is a square-wave with an average amplitude of 15 mA and is equally distributed from the frontal region to the mastoid areas (amplitudes are reported as zero-to-peak).
All participants with major depression disorder will receive a total of 20 sessions in four weeks, once daily on weekdays, with tACS stimulation at 77.5 Hz and 15 mA.
From Monday to Friday, each session will last 40 min at a fixed daytime interval.
干预措施: tACS (Device)
Healthy controls
Without the tACS stimulation in this group
干预措施: Control (Other)
结局指标
主要结局
The changes in quantitative MPPF values before and after the tACS intervention.
时间窗: baseline (before the tACS intervention), 4 weeks (after the tACS intervention)
Twenty patients with depressive disorders will receive 18F-MPPF PET/MR imaging before and after the tACS intervention. MPPF metabolism values in different brain regions will be calculated. A comparative analysis will be then performed between the baseline and post-treatment in patients with depressive disorders.
次要结局
- The changes in scores for Pittsburgh Sleep Quality Index (PSQI) before and after the tACS intervention.(baseline, 4 weeks)
- The changes in scores for 17-item Hamilton Depression Rating Scale (HAMD-17) before and after the tACS intervention.(baseline, 4 weeks)
- The changes in scores for Generalized Anxiety Disorder-7 item (GAD-7) before and after the tACS intervention.(baseline, 4 weeks)
- The changes in scores for Insomnia Severity Index (ISI) before and after the tACS intervention.(baseline, 4 weeks)
- Cognitive changes will be assessed using the Montreal Cognitive Assessment (MoCA) before and after the tACS intervention in depression.(baseline, 4 weeks)
- Cognitive changes will be assessed using the Mini-Mental State Examination (MMSE) before and after the tACS intervention in depression.(baseline, 4 weeks)
- The changes in scores for Hamilton Anxiety Rating Scale (HAMA) before and after the tACS intervention.(baseline, 4 weeks)