fMRI Neurofeedback With Matter Neuroscience App

Stanford-Matter Neuroscience High-Resolution fMRI Advanced Neurofeedback Feasibility Trial (fMRI Neurofeedback) Medical

Study will utilize an app, Matter Neuroscience, designed to help users with depression understand positive emotions and the neurotransmitters that create them. We hope to learn the safety and efficacy of neurofeedback for treating depression and lay the groundwork for a pivotal clinical trial.

Study Overview

• Status: Recruiting
• Conditions: Depression; Depression Moderate; Depression Mild
• Intervention / Treatment: Device: Matter Neuroscience App; Other: No Home Training; Other: Stock Photos; Device: Personal Photos; Other: Home Training

Detailed Description

The Matter Neuroscience application, available through the Apple App Store, is designed to help users understand positive emotions and the neurotransmitters that create them. The application allows users to collect good moments by adding photos and other information to the application and activating positive emotions when the photos and other information are viewed. When positive emotions are activated, the application allows users to quickly rate the positive emotions felt during moments. The data collected is translated into the user's Matter Score. Tracking the user's Matter Score can allow them to see how they are doing from the inside out. Neurotransmitter activity helps build neuroplasticity in the brain. Higher levels of neuroplasticity correlate with higher levels of creativity, intelligence, and empathy as well as longer, healthier, happier lifespans. The 7TMRI Scanner will be used to gather structural and functional brain data.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nick Bassano; Phone Number: 650-800-6920; Email: nbassano@stanford.edu
• Study Contact Backup: Name: Stephanie Wan; Phone Number: 650 491 6339; Email: stephwan@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Recruiting
      • Stanford University Brain Stimulation Lab
      • Principal Investigator: David Spiegel, MD
      • Contact: Nick Bassano, MSW; Phone Number: 650-800-6920; Email: nbassano@stanford.edu
      • Contact: Stephanie Wan; Phone Number: 650-491-6339; Email: stephwan@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or Female, between the ages of 18 and 80 at the time of screening.
2. Primary diagnosis of nonpsychotic major depressive disorder (MDD) without a history of psychotic features.
3. Score on the MADRS scale between 15-25
4. Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
5. Must possess an iPhone with the latest iOS version compatible with the app or must be willing to use a loaner iPhone from the study if available.
6. Has had at least one lifetime antidepressant treatment failure (ATHF)
7. The dose of the primary antidepressant medication (if applicable) must be stable for 4 weeks prior to baseline, and participants must agree to continue at this dose throughout the study period.
8. In good general health, as evidenced by medical history and determined by study physician
9. For women of reproductive potential: agree to the use of highly effective contraception during study participation.
10. Adequate visual acuity (with or without corrective lenses) to view study materials while in the MRI.
11. Agreement to adhere to Lifestyle Considerations throughout study duration.

Exclusion Criteria:

1. Contraindication to MRI (ferromagnetic metal in their body)
2. Severe claustrophobia
3. Women that are pregnant or breastfeeding or with a positive urine pregnancy test at participation, or who are planning to become pregnant during the study period.
4. Primary psychiatric condition other than MDD requiring treatment except stable comorbid anxiety disorder
5. History of or current psychotic disorder, schizophrenia, psychosis, bipolar disorder, or severe borderline personality disorder.
6. Diagnosis of intellectual disability, autism spectrum disorder, or other neurodevelopmental disorder.
7. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal
8. Urine screening test positive for recent use of recreational drugs except for marijuana..
9. Considered at significant risk for suicide during the course of the study.
10. Recent (within 4 weeks of any clinical effect) or concurrent use of rapid acting antidepressant agent (i.e., a course of ECT or TMS). Excluding ketamine.
11. History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma as determined by the PD.
12. Untreated or insufficiently treated endocrine or metabolic disorder.
13. Any other condition deemed by the PD to interfere with the study or increase risk to the participant
14. Alexithymia as determined by the Toronto Alexithymia Scale
15. Treatment with an investigational drug or other intervention within the study period.
16. Not currently in a major depressive episode as defined by the MINI.
17. More than 5 lifetime adequate antidepressant medication failures (ATHF).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 2. No home training, neurofeedback, stock photos, repeated scans; No home training, neurofeedback, stock photos, repeated scans	Device: Matter Neuroscience App; An iPhone smartphone application; Other: No Home Training; No Home Training; Other: Stock Photos; Stock Photos
Experimental: Arm 3. No home training, neurofeedback, personal photos, repeated scans; No home training, neurofeedback, personal photos, repeated scans	Device: Matter Neuroscience App; An iPhone smartphone application; Other: No Home Training; No Home Training; Device: Personal Photos; Personal Photos
Experimental: Arm 4. Home training, no neurofeedback, stock photos, repeated scans; Home training, no neurofeedback, stock photos, repeated scans	Device: Matter Neuroscience App; An iPhone smartphone application; Other: Stock Photos; Stock Photos; Other: Home Training; Home Training
Experimental: Arm 5. Home training, neurofeedback, stock photos, repeated scans; Home training, neurofeedback, stock photos, repeated scans	Device: Matter Neuroscience App; An iPhone smartphone application; Other: Stock Photos; Stock Photos; Other: Home Training; Home Training
Experimental: Arm 6. Home training, no neurofeedback, personal photos, repeated scans; Home training, no neurofeedback, personal photos, repeated scans	Device: Matter Neuroscience App; An iPhone smartphone application; Device: Personal Photos; Personal Photos; Other: Home Training; Home Training
Experimental: Arm 7. Home training, neurofeedback, personal photos, repeated scans; Home training, neurofeedback, personal photos, repeated scans	Device: Matter Neuroscience App; An iPhone smartphone application; Device: Personal Photos; Personal Photos; Other: Home Training; Home Training
No Intervention: Arm 1A. No home training, no neurofeedback, no photos, no repeated scans; No home training, no neurofeedback, no photos, no repeated scans
Experimental: Arm 1B. No home training no neurofeedback, repeated scans, personal photos; No home training no neurofeedback, repeated scans, personal photos	Device: Matter Neuroscience App; An iPhone smartphone application; Other: No Home Training; No Home Training; Device: Personal Photos; Personal Photos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the safety and efficacy of neurofeedback for treating depression through MADRS scale changes	Determine the safety and efficacy of neurofeedback for treating depression through MADRS (Montgomery-Åsberg Depression Rating Scale) scale changes. The 9-item self-report version of the MADRS has an overall score range from 0-27, with higher scores corresponding to higher levels of depression.	Screening, Baseline, Immediate Post, One Month Post, Three Month and Optional Six Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure fMRI Change	Measure fMRI Change	Baseline, Week 2, Week 4, Week 6, Immediate Post, Optional Three Month Post Scan

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: David Spiegel, MD, Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2028

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: 77871

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No