fMRI neurofeedback using the Matter app for depression

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

This trial will try fMRI-based neurofeedback delivered through the Matter Neuroscience app to see if it helps adults with mild to moderate major depressive disorder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Locations: 1 site (Stanford, California)
• Trial ID: NCT06735885 on ClinicalTrials.gov

What this trial studies

The study uses the Matter Neuroscience mobile app together with functional MRI neurofeedback sessions to train participants to recognize and increase brain activity linked to positive emotions. Participants will complete in-person fMRI neurofeedback visits at Stanford and perform app-based home training using personal or stock photos. Eligible adults (18–80) must have nonpsychotic major depressive disorder with MADRS scores 15–25, own a compatible iPhone, and have 1–5 prior adequate antidepressant failures with stable dosing. The primary goals are to gather safety data, preliminary efficacy signals, and feasibility information to inform a future pivotal trial.

Who should consider this trial

Good fit: Adults aged 18–80 with primary nonpsychotic major depressive disorder, a MADRS score of 15–25, ownership of a compatible iPhone, and 1–5 prior adequate antidepressant failures are the ideal candidates.

Not a fit: Patients with psychotic features, MADRS scores outside the 15–25 range, unstable antidepressant dosing, or without a compatible iPhone are unlikely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could reduce depressive symptoms by teaching patients to upregulate positive-emotion brain signals using neurofeedback.

How similar studies have performed: Small, preliminary fMRI neurofeedback studies for depression have shown promising but mixed results, so this approach remains experimental.

Eligibility criteria

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, and be capable of using the study app with the phone.
6. 1-5 lifetime adequate antidepressant medication failures (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. 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.
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.

Where this trial is running

Stanford, California

• Stanford University Brain Stimulation Lab — Stanford, California, United States (Recruiting)

Study contacts

• Principal investigator: David Spiegel, MD — Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine
• Study coordinator: Nick Bassano, MS

Conditions Depression Mild; Depression; Depression Moderate