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

NCT06982820 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-05-01

No results posted yet for this study

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).

Conditions

  • Depressive Disorder, Major

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.

Sponsors & Collaborators

  • GrayMatters Health Ltd.

    lead INDUSTRY

Principal Investigators

  • Aron Tendler, MD · GrayMatters Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2027-05-30
Completion
2027-08-30
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06982820 on ClinicalTrials.gov