NCT05869708

PRISM Neurofeedback Training for MDD Anhedonic Patients

Personalizing Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia Using Clinical Biomarkers for MDD Subtypes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: GrayMatters Health Ltd. · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 at least 10 sessions but optimally 15 (+/-3) neurofeedback training sessions (performed twice a week on nonconsecutive days for 5-8 weeks). * 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.

Conditions

• Depression
• Anhedonia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-09-03
• Completion: 2025-09-03
• First posted: 2023-05-22
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study