跳至主要内容
临床试验/NCT06211140
NCT06211140招募中不适用

Effect of Transcranial Alternating Current Stimulation (tACS) on Serotonin-1A Receptor in Patients With Major Depressive Disorder

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月31日最近更新:
适应症

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

入选标准

  • 未提供

排除标准

  • 未提供

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 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)
  • The changes in scores for Pittsburgh Sleep Quality Index (PSQI) before and after the tACS intervention.(baseline, 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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