fMRI Neurofeedback With Matter Neuroscience App

NCT ID: NCT06735885

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-12

Study Completion Date

2028-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Depression Mild Depression Depression Moderate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

Home training, no neurofeedback, stock photos, repeated scans

Group Type EXPERIMENTAL

No interventions assigned to this group

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

Home training, neurofeedback, stock photos, repeated scans

Group Type EXPERIMENTAL

No interventions assigned to this group

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

Home training, no neurofeedback, personal photos, repeated scans

Group Type EXPERIMENTAL

No interventions assigned to this group

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

Home training, neurofeedback, personal photos, repeated scans

Group Type EXPERIMENTAL

No interventions assigned to this group

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

No home training no neurofeedback, repeated scans

Group Type EXPERIMENTAL

No interventions assigned to this group

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

No home training, neurofeedback, stock photos, repeated scans

Group Type EXPERIMENTAL

No interventions assigned to this group

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

No home training, neurofeedback, personal photos, repeated scans

Group Type EXPERIMENTAL

No interventions assigned to this group

Interventions

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Matter Neuroscience App

An iPhone smartphone application

Intervention Type DEVICE

Stock Photos

Stock Photos

Intervention Type OTHER

No Home Training

No Home Training

Intervention Type OTHER

Personal Photos

Personal Photos

Intervention Type DEVICE

Home Training

Home Training

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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David Spiegel

Professor and Associate Chair of Psychiatry & Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Spiegel, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine

Locations

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Stanford University Brain Stimulation Lab

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nick Bassano, MS

Role: CONTACT

650-800-6920

Noriah Johnson

Role: CONTACT

650-800-6920

Facility Contacts

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Nick Bassano, MSW

Role: primary

650-800-6920

Noriah Johnson

Role: backup

650-800-6920

Other Identifiers

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77871

Identifier Type: -

Identifier Source: org_study_id