跳至主要内容
临床试验/NCT05634941
NCT05634941招募中不适用

Effect of Transcranial Direct Current Stimulation of the Greater Occipital Nerve on Memory Function Improvement and and the Locus Coeruleus-Noradrenergic Circuits in Stable Depression Patients

First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Change in working memory test scores after intervention.

研究概览

简要总结

So far, antidepressant drugs have limited memory improvement. Transcranial direct current stimulation, as a non-invasive and safe neuroregulatory technique, is a new direction to improve memory.In this study, transcranial direct current stimulation of the greater occipital nerve was used to explore the effect of improving memory function in patients with stable depression, and related studies were conducted on the locus coeruleus-noadrenal loop and the functional connection between locus coeruleus, hippocampus and amygdala.

详细描述

In this study, a randomized, controlled, double-blind design was adopted. Patients with depression were randomly divided into an intervention group and a control group to receive true or fake tDCS stimulation respectively. Clinical data, memory and other related cognitive function assessment, EEG, resting state fMRI, saliva and blood indicators were collected two weeks before and two weeks after the intervention, and followed up for eight weeks. Finally, data correlation analysis was performed.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible for ICD-10 depressive episode (F32) or recurrent depressive disorder (F33) diagnosis;
  • Antidepressant therapy for at least 8 weeks, with no antidepressant adjustment for nearly 2 months
  • HAMD-17 scores ≤ 7 points at the time of enrollment; CGI score ≦2;
  • Chief complaint of memory impairment, PDQ-D score of cognitive impairment ≧17 points;
  • Right-handed.

排除标准

  • A history of major physical diseases;
  • Have other mental disorders that meet the diagnostic criteria of ICD-10;
  • Hearing, color blindness, color weakness or receive electroconvulsive therapy;
  • Alcohol dependence or substance abuse;
  • Patients with intellectual disability;
  • Pregnant or lactating women or those planning to become pregnant;
  • Patients with contraindications to tDCS.

结局指标

主要结局

Change in working memory test scores after intervention.

时间窗: Baseline, 2-week, 2-month

The working memory test consists of two parts, which measure the breadth and accuracy of working memory respectively. The breadth of working memory will be tested using the operating span experiment, as the accuracy of working memory will be tested using the Memory Orientation experiment.

次要结局

  • Change in the test of logical memory on the Wechsler Memory Test score after intervention.(Baseline, 2-week, 2-month)
  • Change in three component test of executive function scores after intervention.(Baseline, 2-week, 2-month)

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验