NCT05178784

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Butler Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
DEVICE	External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) stimulation	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.

Timeline

• Start date: 2021-11-16
• Primary completion: 2024-12-03
• Completion: 2025-11-16
• First posted: 2022-01-05
• Last updated: 2024-12-05

Locations

1 site across 1 country: United States