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

Active, not recruiting

• Conditions: Depression
• Interventions: Device: External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) stimulation

• Registration Number: NCT05178784
• Lead Sponsor: Butler Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-11-16
• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2022-01-05
• Status Verified: 2024-12
• Primary Completion: 2024-12-03
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Study Completion: 2025-11-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active Stimulation	External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) stimulation	Adults exposed to active external Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) stimulation during the 8-week blinded treatment phase of the MOOD Clinical Trial (NCT04279522) who enrolled in this EEG substudy

Primary Outcome Measures

Name	Time	Method
Change in Frontal Alpha Power	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)

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States