fMRI Neurofeedback With Matter Neuroscience App

Stanford University

Status: Enrolling

Conditions: Depression Mild; Depression Moderate; Depression

Treatments: Device: Matter Neuroscience App; Other: No Home Training; Other: Stock Photos; Device: Personal Photos; Other: Home Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06735885

77871

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 8 patient groups

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

No Intervention group

Description:

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

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

Experimental group

Description:

No home training no neurofeedback, repeated scans

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

Experimental group

Description:

No home training, neurofeedback, stock photos, repeated scans

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

Experimental group

Description:

No home training, neurofeedback, personal photos, repeated scans

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

Experimental group

Description:

Home training, no neurofeedback, stock photos, repeated scans

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

Experimental group

Description:

Home training, neurofeedback, stock photos, repeated scans

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

Experimental group

Description:

Home training, no neurofeedback, personal photos, repeated scans

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

Experimental group

Description:

Home training, neurofeedback, personal photos, repeated scans