fMRI Neurofeedback With Matter Neuroscience App

NCT06735885 | Recruiting

• 1 other identifier: 77871
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression Mild; Depression; Depression Moderate

Outcome Measures

Primary Outcomes (1)

• 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, Optional Three Month and Optional Six Month

Secondary Outcomes (1)

• Measure fMRI Change

  Baseline, Week 2, Week 4, Week 6, Immediate Post, Optional Three Month Post Scan

Study Arms (8)

Arm 1A. No home training, no neurofeedback, no photos, no repeated scans, personal photos

NO INTERVENTION

No home training, no neurofeedback, no photos, no repeated scans, personal photos

Arm 1B. No home training no neurofeedback, repeated scans

EXPERIMENTAL

No home training no neurofeedback, repeated scans

Arm 2. No home training, neurofeedback, stock photos, repeated scans

EXPERIMENTAL

No home training, neurofeedback, stock photos, repeated scans

Arm 3. No home training, neurofeedback, personal photos, repeated scans

EXPERIMENTAL

No home training, neurofeedback, personal photos, repeated scans

Arm 4. Home training, no neurofeedback, stock photos, repeated scans

EXPERIMENTAL

Home training, no neurofeedback, stock photos, repeated scans

Arm 5. Home training, neurofeedback, stock photos, repeated scans

EXPERIMENTAL

Home training, neurofeedback, stock photos, repeated scans

Arm 6. Home training, no neurofeedback, personal photos, repeated scans

EXPERIMENTAL

Home training, no neurofeedback, personal photos, repeated scans

Arm 7. Home training, neurofeedback, personal photos, repeated scans

EXPERIMENTAL

Home training, neurofeedback, personal photos, repeated scans

Interventions

Personal Photos DEVICE

Personal Photos

Home Training OTHER

Home Training

Stock Photos OTHER

Stock Photos

No Home Training OTHER

No Home Training

Matter Neuroscience App DEVICE

An iPhone smartphone application

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, between the ages of 18 and 80 at the time of screening.
• Primary diagnosis of nonpsychotic major depressive disorder (MDD) without a history of psychotic features.
• Score on the MADRS scale between 15-25
• 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.
• Must possess an iPhone with the latest iOS version compatible with the app, and be capable of using the study app with the phone.
• lifetime adequate antidepressant medication failures (ATHF).
• 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.
• In good general health, as evidenced by medical history and determined by study physician
• For women of reproductive potential: agree to the use of highly effective contraception during study participation.
• Adequate visual acuity (with or without corrective lenses) to view study materials while in the MRI.
• Agreement to adhere to Lifestyle Considerations throughout study duration.

You may not qualify if:

• \. Contraindication to MRI (ferromagnetic metal in their body)
• Severe claustrophobia
• 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.
• Primary psychiatric condition other than MDD requiring treatment except stable comorbid anxiety disorder
• History of or current psychotic disorder, schizophrenia, psychosis, bipolar disorder, or severe borderline personality disorder.
• Diagnosis of intellectual disability, autism spectrum disorder, or other neurodevelopmental disorder.
• Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal
• Urine screening test positive for recent use of recreational drugs.
• Considered at significant risk for suicide during the course of the study.
• 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.
• 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.
• Untreated or insufficiently treated endocrine or metabolic disorder.
• Any other condition deemed by the PD to interfere with the study or increase risk to the participant
• Alexithymia as determined by the Toronto Alexithymia Scale
• Treatment with an investigational drug or other intervention within the study period.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Brain Stimulation Lab

Stanford, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• David Spiegel, MD

  Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nick Bassano, MS

CONTACT

650-800-6920; nbassano@stanford.edu

Noriah Johnson

CONTACT

650-800-6920; noriah@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Chair of Psychiatry & Behavioral Sciences

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: August 12, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)