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

NCT05178784 | Active Not Recruiting

• 1 other identifier: 1823167
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Active 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

Device: External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) stimulation

Sham Stimulation

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

Interventions

External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) stimulation DEVICE

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.

Also known as: eCOT-NS

Active Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with a primary diagnosis of MDD; ages 18-70; with current episode of primary depression lasting up to 3 years; at least moderate symptom severity reflected by score on HAMD17 scale at baseline \>20; history of antidepressant medication treatment resistance or intolerance and curently on stable dose of current antidepressant medication.

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Butler Hospital: lead
• Neurolief Ltd.: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Linda Carpenter, MD

  Butler Hospital/Brown University Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: November 16, 2021
• Primary Completion: December 3, 2024
• Study Completion: November 16, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)