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

NCT05178784 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2024-12-05

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Neurolief Ltd.

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Butler Hospital

    lead OTHER

Principal Investigators

  • Linda Carpenter, MD · Butler Hospital/Brown University Department of Psychiatry

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-16
Primary Completion
2024-12-03
Completion
2025-11-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05178784 on ClinicalTrials.gov