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临床试验/NCT05178784
NCT05178784进行中(未招募)不适用

EEG Biomarker Study for Participants in the Neurolief "MOOD" Trial

Butler Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Change in Frontal Alpha Power

研究概览

简要总结

This study will collect EEG data at 3 time points from up to 40 adults who are enrolled in a double clinical trial investigating a device that delivers noninvasive, self-administered external Combined Occipital and Trigeminal Neurostimulation (eCOT-NS) treatment for Major Depressive Disorder (Relivion®DP). Baseline (Pre-treatment) Frontal EEG Alpha Oscillations (Power) will be compared post-stimulation power.

详细描述

EEG Biomarkers may be useful for understanding abnormal brain oscillations associated with Major Depressive Disorder (MDD) and other psychiatric disorders as well as the brain changes that occur when symptoms remit. This study will invite adults with MDD who enroll and are randomized in the Neurolief Sponsored "MOOD" study to undergo collection of EEG data at pre-treatment baseline, again after completing the 8-week blinded treatment phase, and, if eligible/appropriate, again after completing an 8-week open-label treatment phase. EEG will be recorded at rest and during a computer task. This EEG "add-on" study is observational in nature, as it will not manipulate the treatment assignment in the MOOD clinical trial or otherwise impact concurrently ongoing treatments for any condition. Researchers collecting and analyzing EEG data will be blinded to treatment assignment when participants are in the double-blinded treatment phase of the MOOD clinical trial. EEG data will be processed and analyzed to evaluate changes in frontal alpha oscillations associated with 8 weeks of active Relivion®DP stimulation.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meets all criteria for participation in the Neurolief-sponsored MOOD clinical trial (NCT04279522) and has been randomized to a treatment group for the double-blind phase.
  • Is willing and able to participate in up to 3 additional research visits for EEG data collections.

排除标准

  • 未提供

结局指标

主要结局

Change in Frontal Alpha Power

时间窗: 8 weeks

Change from Pre- to Post- Stimulation Power in Frontal Electrodes at Individual Alpha Frequency Peak (IAF), as recorded in resting state EEG. Calulated as (post-pre)/ (pre+post)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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