fMRI Neurofeedback With Matter Neuroscience App

July 1, 2026 updated by: David Spiegel, Stanford University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94304
        • Recruiting
        • Stanford University Brain Stimulation Lab
        • Principal Investigator:
          • David Spiegel, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: 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
Other: Home Training
Home Training
Other: Personal Photos
Personal Photos
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
Other: Home Training
Home Training
Other: Personal Photos
Personal Photos
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
Other: Personal Photos
Personal Photos

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determine the safety and efficacy of neurofeedback for treating depression through MADRS scale changes
Time Frame: Screening, Baseline, Immediate Post, One Month Post, Three Month and Optional Six Month

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measure fMRI Change
Time Frame: Baseline, Week 2, Week 4, Week 6, Immediate Post, Optional Three Month Post Scan
Measure fMRI Change
Baseline, Week 2, Week 4, Week 6, Immediate Post, Optional Three Month Post Scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Spiegel, MD, Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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