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EEG Biomarker Study for Participants in the Neurolief "MOOD" Trial
Sponsor: Butler Hospital
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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
OBSERVATIONAL
Enrollment
40
Start Date
2021-11-16
Completion Date
2025-11-16
Last Updated
2024-12-05
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Butler Hospital
Providence, Rhode Island, United States