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PRISM Neurofeedback Training for MDD Anhedonic Patients

NCT05869708 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-09-05

No results posted yet for this study

Summary

The goal of this interventional double-blind study is to demonstrate the safety and efficacy of PRISM neurofeedback training within an MDD Anhedonia sample.

The goals of this study include:

1. Demonstrating the safety and efficacy of Prism Neurofeedback training within an MDD Anhedonia sample;
2. Identifying clinical profile/symptoms-based biomarkers (e.g., Hamilton Depression Rating Scale - HDRS-21, Dimensional Anhedonia Rating Scale - DARS, Snaith-Hamilton Pleasure Scale for Clinicians SHAPS) scores that can be used by clinics to administer Prism therapy in conjunction with standard of care (SOC) therapy;
3. Producing initial guidelines for integrating Prism neurofeedback training for MDD therapy with MDD Anhedonia (SOC).

Participants will be randomly assigned to one of two arms, Active, or Sham.

Conditions

Interventions

DEVICE

Active RS-EFP

A minimum of 10 and up to 15 active NF Prism training sessions, aimed to train for upregulating the RS activity. Sessions will occur twice a week, on nonconsecutive days, over 5-8 consecutive weeks. Subjects will also receive two single booster sessions, one month and two months after their last training session.

DEVICE

Sham RS-EFP

a minimum of 10 and up to 15 sham NF Prism training sessions, aimed to train for upregulating the RS activity. Sessions will occur twice a week, on nonconsecutive days, over 5-8 consecutive weeks. Subjects will also receive two single sham booster sessions, one month and two months after their last training session.

Sponsors & Collaborators

  • GrayMatters Health Ltd.

    lead INDUSTRY

Principal Investigators

  • Diego Pizzagalli, PhD · Mclean Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-09-03
Completion
2025-09-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT05869708 on ClinicalTrials.gov