fMRI Neurofeedback With Matter Neuroscience App
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Matter Neuroscience App
DeviceAn iPhone smartphone application
Stock Photos
Other interventionStock Photos
No Home Training
Other interventionNo Home Training
Personal Photos
Other interventionPersonal Photos
Home Training
Other interventionHome Training
Treatment groups
240 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Arm 1A. No home training, no neurofeedback, no photos, no repeated scansNo intervention 0 interventions
Group B: Arm 1B. No home training no neurofeedback, repeated scans, personal photosExperimental treatment 3 interventions
Group C: Arm 2. No home training, neurofeedback, stock photos, repeated scansExperimental treatment 3 interventions
Group D: Arm 3. No home training, neurofeedback, personal photos, repeated scansExperimental treatment 3 interventions
Group E: Arm 4. Home training, no neurofeedback, stock photos, repeated scansExperimental treatment 3 interventions
Group F: Arm 5. Home training, neurofeedback, stock photos, repeated scansExperimental treatment 3 interventions
Group G: Arm 6. Home training, no neurofeedback, personal photos, repeated scansExperimental treatment 3 interventions
Group H: Arm 7. Home training, neurofeedback, personal photos, repeated scansExperimental treatment 3 interventions
Trial outcomes
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.
Time frame
Screening, Baseline, Immediate Post, One Month Post, Three Month and Optional Six MonthSecondary outcomes
1
Measure fMRI Change
Measure fMRI Change
Time frame
Baseline, Week 2, Week 4, Week 6, Immediate Post, Optional Three Month Post ScanSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov