EEG Biomarker Study for Participants in the Neurolief MOOD Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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EEG Biomarker Study for Participants in the Neurolief MOOD Trial

Conditions
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Depression

Intervention / Treatment
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* Device: External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Stimulation<br>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 | Device: External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) stimulation<br>* Relivion®DP is a device by Neurolief that delivers external, combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS), which is proposed as a novel treatment approach for MDD. The Relivion®DP device is designed for at-home self-administration by patients; it is comprised of a headset that holds electrodes, and it is worn externally on a person's head. When activated, the device delivers mild electrical stimulation pulses which can be managed by the user. The stimulation is intended to reduce MDD symptoms.<br>* Other names: eCOT-NS;|
| Sham Stimulation<br>Adults exposed to sham 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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Frontal Alpha Power | 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) | 8 weeks |