NCT06982820

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: GrayMatters Health Ltd. · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study is comprised of the Screening Visit, Baseline Assessment, Pre-training Visit, 20 NF Training Visits (two training visits per week over 10 weeks), two Booster NF Training Visits (Week 16, and Week 20, and the 3-Month Follow-up Assessment Visit (Week 24). Participants will receive 20 NF sessions. The study will test the following hypothesis: * H0: M(Anhedonic)RS-EFP = M(Anhedonic)Sham-EFP * H1: M(Anhedonic)RS-EFP ≠ M(Anhedonic)Sham-EFP Where: M(Anhedonic)RS-EFP and M(Anhedonic)Sham-EFP are the mean changes from baseline HDRS-17 score in the Active and Sham arms of the Anhedonic MDD participants. \*HDRS-21 is administered for cluster analysis

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-25
• Primary completion: 2027-05-30
• Completion: 2027-08-30
• First posted: 2025-05-21
• Last updated: 2026-03-04

Locations

3 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated device study