RecruitingNot ApplicableNCT06982820

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

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


Sponsor

GrayMatters Health Ltd.

Enrollment

170 participants

Start Date

Jun 25, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 22 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a brain-computer interface (BCI) approach called "self neuromodulation therapy" for people with major depression who also experience anhedonia — a loss of pleasure or interest in activities. Participants wear a headset that records brain activity and receive feedback to help train their brains to shift toward healthier patterns of activity. **You may be eligible if...** - You are an adult diagnosed with major depressive disorder (MDD) with anhedonia - You have moderately severe depression (score of 20 or above on a standard rating scale) and significant anhedonia - You have tried at least one antidepressant medication at an adequate dose and duration during your current episode - You can speak and read English fluently, have normal or corrected vision and hearing **You may NOT be eligible if...** - You have metal implants in your body or claustrophobia (which prevents MRI scanning) - You have had a suicide attempt or self-harm behavior in the past year - You currently have moderate or severe substance or alcohol use disorder - You have an unstable medical condition that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPrism 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

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NCT06982820


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