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RECRUITING
NCT06982820
NA

Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia

Sponsor: GrayMatters Health Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this research is to learn more about a new treatment for individuals with Major Depressive Disorder (MDD) with heightened symptoms of anhedonia (i.e. loss of pleasure or interest in activities). The treatment is called Prism, and it is a software device intended for a novel form of neurofeedback training to be used in a clinic setting. During this study, the subject will use different techniques to measure brain activities, including magnetic resonance imaging (MRI) and electroencephalography (EEG).

Official title: A Prospective, Randomized, Double-blind, Controlled Study to Produce Guidelines for Integrating Prism for MDD Therapy (Reward System [RS] Upregulation) and to Demonstrate Its Superiority Over Sham Therapy

Key Details

Gender

All

Age Range

22 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2025-06-25

Completion Date

2027-08-30

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DEVICE

Prism Training

Participants will complete 20 Prism training sessions. The Prism training sessions take place twice a week over a 10-week period, with a minimum of one night of sleep between sessions. Participants will also receive two single booster sessions, 4 weeks and 8 weeks after their last NF session completed.

Locations (3)

Butler Hospital

Providence, Rhode Island, United States

Houston Center For Advanced Psychiatric Treatment

Houston, Texas, United States

Sheba Medical Center

Ramat Gan, Israel