GrayMatters Health Ltd.
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 main questions it aims to answer are: what clinical profile / symptoms-based biomarkers scores can be used by clinics to administer PRISM therapy in conjunction with standard care of therapy? What are the initial guidelines for integrating PRISM neurofeedback training for MDD therapy with MDD Anhedonia? Participants will be randomly assigned to one of two arms, Active, or Sham. During the study, participants will perform the following: Complete clinical assessments using questionnaires, an MRI scan, and tasks that probe reward responsivity, learning, and motivation. Perform 15 (+/-3) neurofeedback training sessions (performed twice a week on nonconsecutive days for about 2 months). Complete the same clinical assessments, post-NF training MRI scan, and tasks same as in the screening/baseline stage. Researchers will compare the sham and treatment arm to evaluate if the neurofeedback effect reduced MDD symptoms in MDD patients with Anhedonia.
Depression
Anhedonia
Active RS-EFP
Sham RS-EFP
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 80 participants |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Personalizing Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia Using Clinical Biomarkers for MDD Subtypes |
Actual Study Start Date : | July 1, 2023 |
Estimated Primary Completion Date : | May 1, 2025 |
Estimated Study Completion Date : | May 1, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Active Arm Subjects randomized into the Active arm will receive RS-EFP-NF Prism training as an adjunct to standard of care. |
Device: Active RS-EFP |
Sham Comparator: Control Arm Subjects randomized into the Control arm will receive a Sham-EFP-NF training with the same schedule as the active arm, adjunct to standard of care. |
Device: Sham RS-EFP |
Ages Eligible for Study: | 22 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
McLean Hospital
Belmont, Massachusetts, United States, 02478