RecruitingNot applicable

fMRI Neurofeedback With Matter Neuroscience App

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether neurofeedback, which gives feedback about brain activity during an MRI scan, is safe and helps treat depression. It uses the Matter Neuroscience app to help people understand positive feelings and the brain chemicals behind them. It is for adults ages 18 to 80 with major depression who have tried at least one antidepressant that did not work.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 to 80 with major depression as your main diagnosis and no history of losing touch with reality. Have a score of 15 to 25 on the MADRS depression scale.
  • Have tried at least one antidepressant treatment that did not work.
  • Read and understand English well enough to follow directions and answer questions. Give written consent before screening.
  • Agree to follow study steps and lifestyle rules, stay available for the study, and report side effects or other important health changes.
  • Have an iPhone with the latest app-compatible software, or agree to use a study loaner if one is available.
  • If you take a main antidepressant, have kept the same dose for 4 weeks before the study's starting visit and agree to keep it during the study.
  • Be in good general health, as judged by the study doctor, and see well enough to view materials in the MRI, with glasses or contacts if needed.
  • If you are a woman who can become pregnant, agree to use highly effective birth control during the study.

Who can't join

  • Have metal in your body that makes MRI unsafe, or a severe fear of tight spaces.
  • Be pregnant, breastfeeding, have a positive pregnancy test, or plan to become pregnant during the study.
  • Have another main mental health condition needing treatment, except a stable anxiety disorder; a past or current disorder involving loss of touch with reality; bipolar disorder; or severe borderline personality disorder. Intellectual disability, autism, and other brain development disorders also exclude you.
  • Have a current moderate or severe substance use disorder, signs of sudden withdrawal, or a positive urine test for recent recreational drug use other than marijuana.
  • Have a high suicide risk, not be in a current major depression episode on the MINI interview, or have had more than 5 adequate antidepressant medicine trials that did not work.
  • Have a serious brain or nerve disease or major head injury; an untreated or poorly treated hormone or metabolism disorder; or another condition that study staff judge unsafe or likely to affect the study.
  • Have trouble identifying and describing feelings, called alexithymia, based on the Toronto Alexithymia Scale.
  • Use a rapid-acting depression treatment, such as ECT or TMS brain stimulation, now or recently under the study's 4-week rule; this rule does not include ketamine. Receiving an experimental drug or other treatment during the study also excludes you.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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 sites (1)

CA