Neurofeedback to Treat Depression

MDD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05169346
• Other study ID #: 849298
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Pennsylvania
• Contact: Frederick Nitchie
• Phone: (215) 573-9058
• Email: frederick.nitchie[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study tests the efficacy of a new psychotherapeutic strategy for reducing negative attention bias (and therefore depression severity) in participants with MDD (60 in R61 phase and 80 in R33 Phase). 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.

Description:

In both the R61and R33 phases we will compare cloud based real time fMRI feedback with placebo (sham feedback) in reducing negative attention bias and depressive symptoms. This study will be the first dose-finding test of real-time fMRI effect on negative attention bias. Measures include: Structured Clinical Interview for DSM-5 (SCID), Clinician-administered diagnostic exam, Montgomery Asberg Depression Rating Scale (MADRS), Clinician-administered scale used to assess the severity of depression, State-Trait Anxiety Inventory (STAI), Self-report questionnaire used to measure types of anxiety and mood symptoms, Mood and Anxiety Symptom Questionnaire (MASQ), Negative perseveration during a go/no-go task, Go/no-go task with overlaid face/scene stimuli; brain response triggers next stimulus, Negative gaze, Negative gaze collected in gaze data following each real time fMRI feedback session

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• MDD

Intervention

Behavioral:
• Active Closed Loop Real Time fMRI Neurofeedback
Active neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)
• Sham Closed Loop Real Time fMRI Neurofeedback
Sham (placebo) neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)

Locations

Country	Name	City	State
United States	Center for Neuromodulation in Depression and Stress	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attention Mechanism of Depression	Associate neurofeedback related changes in our hypothesized attentional mechanism of depression (i.e. neural perseveration of negative states) with changes in depression severity as measured by the Montgomery Asberg Depression Rating Scale (MADRS).	5 years