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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05178784
• Other study ID #: 1823167
• Status: Enrolling by invitation
• Start date: November 16, 2021
• Est. completion date: November 16, 2024

Study information

• Verified date: December 2023
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: November 16, 2024
• Est. primary completion date: November 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

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.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Butler Hospital	Neurolief Ltd., University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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