Real-time fMRI neurofeedback to reduce negative attention bias in depression

Reducing Neural Perseveration Through Closed Loop Real Time fMRI Neurofeedback to Alleviate Depressive Symptoms

This trial will see if cloud-based real-time fMRI neurofeedback can reduce negative attention bias and improve depressive symptoms in adults with major depressive disorder who are not taking psychiatric medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Pennsylvania (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT07159061 on ClinicalTrials.gov

What this trial studies

Adults (18–65) with major depressive disorder and a minimum MADRS score of 16 will be randomized to receive either active closed-loop real-time fMRI neurofeedback or sham feedback. The system uses cloud-based pattern classification to decode each participant's attentional state in real time and dynamically change task stimuli in a closed loop. This is a first-in-human dose-finding test of real-time fMRI effects on negative attention bias, with measures including structured diagnostic interviews, MADRS, STAI, MASQ, go/no-go behavioral tasks with face/scene overlays, and gaze metrics. Participants must be medication-free and able to undergo MRI at the Center for Neuromodulation in Depression and Stress at the University of Pennsylvania.

Who should consider this trial

Good fit: Adults aged 18–65 who meet DSM-5 criteria for major depressive disorder, score at least 16 on the MADRS, are not using psychoactive medications or in psychotherapy, can read English, and can safely undergo MRI would be ideal candidates.

Not a fit: People who are pregnant, outside the 18–65 range, have MRI contraindications, use psychiatric medications or are in therapy, or have severe comorbid psychotic or neurological conditions are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could offer a non-drug approach to reduce negative attention bias and lessen depressive symptoms for some patients.

How similar studies have performed: Previous small real-time fMRI neurofeedback studies have shown promising but mixed effects on emotion and attention, and this cloud-based closed-loop dose-finding approach is novel.

Eligibility criteria

Inclusion Criteria:

* Gender, inclusive
* Adult aged 18 - 65
* Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for MDD according to the Clinician-Administered MDD Scale for DSM-5 (unipolar depression or bipolar II depressed)
* Scores at least a minimum score of 16 on Montgomery Asberg Depression Rating Scale (MADRS)
* Normal cognition
* Participants must be able to read and understand English
* Participants must be able to provide consent

Exclusion Criteria:

* Pregnancy (female participants)
* Outside age range
* MRI contraindications (medical implant, claustrophobia, etc.)
* Use of psychoactive medication (including antidepressants) or currently in therapy
* Neurological disorder or any condition that in the view of the PI could impact brain data, cause depression, require medication that could cause depressive symptoms, or otherwise result in participant being unfit for study (for example, co-morbid psychotic, neurological disorders, developmentally or cognitively disabled/impaired, active alcohol or drug abuse/dependence within the past 6 months).
* Non-English speaking
* Non-correctable vision loss
* Refusal to provide informed consent
* representing an active suicide risk

Where this trial is running

Philadelphia, Pennsylvania

• Center for Neuromodulation in Depression and Stress — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Yvette Sheline, M.D. — Center for Neuromodulation in Depression and Stress, University of Pennsylvania
• Study coordinator: Yvette Sheline, M.D.

Conditions Major Depressive Disorder