fMRI Neurofeedback With Matter Neuroscience App
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or Female, between the ages of 18 and 80 at the time of screening. 2. 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. 3. Must possess an iPhone with iOS 17 or higher. 4. Single-SSRI-resistant depressive disorder patients with a MADRS scale between 20-34
Exclusion Criteria
- Contraindication to MRI (ferromagnetic metal in their body) 2. Claustrophobia 3. Severe Major Depressive Disorder (MDD) 4. MADRS scale of >34 5. Treatment-resistant depression (TRD) from 3 or more treatments. 6. Any other condition deemed by the PD to interfere with the study or increase risk to the participant
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Arm 1A. No home training, no neurofeedback, no photos, no repeated scans (Standard of Care |
No home training, no neurofeedback, no photos, no repeated scans (Standard of Care |
|
|
Experimental Arm 1B. No home training no neurofeedback, repeated scans |
No home training no neurofeedback, repeated scans |
|
|
Experimental Arm 2. No home training, neurofeedback, stock photos, repeated scans |
No home training, neurofeedback, stock photos, repeated scans |
|
|
Experimental Arm 3. No home training, neurofeedback, personal photos, repeated scans |
No home training, neurofeedback, personal photos, repeated scans |
|
|
Experimental Arm 4. Home training, no neurofeedback, stock photos, repeated scans |
Home training, no neurofeedback, stock photos, repeated scans |
|
|
Experimental Arm 5. Home training, neurofeedback, stock photos, repeated scans |
Home training, neurofeedback, stock photos, repeated scans |
|
|
Experimental Arm 6. Home training, no neurofeedback, personal photos, repeated scans |
Home training, no neurofeedback, personal photos, repeated scans |
|
|
Experimental Arm 7. Home training, neurofeedback, personal photos, repeated scans |
Home training, neurofeedback, personal photos, repeated scans |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Stanford University
