Neurofeedback to Treat Depression - 2
Recruiting · NCT07159061 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Pennsylvania
View the official record on ClinicalTrials.gov →Interventions studied
Active Closed Loop Real Time fMRI NeurofeedbackSham Closed Loop Real Time fMRI Neurofeedback
What this trial is about
This study tests the efficacy of a new psychotherapeutic strategy for reducing negative attention bias (and therefore depression severity) in participants with MDD. This real-time fMRI neurofeedback therapy uses cloud-based pattern classification to decode a patient's attentional state and dynamically modulate task stimuli (in a closed loop) based on this state.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Center for Neuromodulation in Depression and Stress - Philadelphia, Pennsylvania, United States