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Behavioural Intervention

Neurofeedback for Depression

N/A
Recruiting
Led By Yael Jacob, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-mri scan at follow up visit day 30
Awards & highlights

Summary

This trial uses an innovative method to reduce rumination in patients with major depressive disorder by targeting connections between two key brain regions.

Who is the study for?
This trial is for adults aged 18-65 with major depressive disorder currently experiencing a depressive episode. They must understand English well enough to consent and participate in the study. Excluded are those with unstable medical conditions, recent CNS-active meds use, pregnancy, high suicide/homicide risk, involuntary psychiatric admission, active substance abuse within 6 months, or history of certain mental disorders.
What is being tested?
The trial tests a new neurofeedback technique using high-resolution MRI to reduce rumination in depression by enhancing brain connectivity between specific regions. Participants will receive real-time feedback from an MRI machine to potentially modulate their brain activity more precisely than traditional methods.
What are the potential side effects?
While there may not be direct side effects from the neurofeedback process itself, participants might experience discomfort or anxiety during the MRI procedure. The high magnetic field can cause sensations such as dizziness or warmth and requires staying still for extended periods.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-mri scan at follow up visit day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-mri scan at follow up visit day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)
Secondary study objectives
Self-reported rumination related to negative affect as measured by Montgomery-Asberg Depression Rating Scale (MADRS)
Self-reported rumination related to negative affect as measured by Perceive Stress Scale (PSS)
Self-reported rumination related to negative affect as measured by Quick Inventory of Depressive Symptomatology (QIDS)
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active NeurofeedbackActive Control1 Intervention
Participants randomized to Active neurofeedback will receive real-time data depicting MOFC-precuneus brain activity while in the scanner.
Group II: Sham NeurofeedbackPlacebo Group1 Intervention
Participants randomized to the Sham neurofeedback control group will receive the feedback of a prior scanned participant's active MOFC-precuneus up-regulation and not their own brain activity. This condition will still visually resemble the active conditions.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
886 Previous Clinical Trials
534,963 Total Patients Enrolled
36 Trials studying Depression
4,451 Patients Enrolled for Depression
Yael Jacob, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

Network Neurofeedback (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05933148 — N/A
Depression Research Study Groups: Active Neurofeedback, Sham Neurofeedback
Depression Clinical Trial 2023: Network Neurofeedback Highlights & Side Effects. Trial Name: NCT05933148 — N/A
Network Neurofeedback (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05933148 — N/A
Depression Patient Testimony for trial: Trial Name: NCT05933148 — N/A
~24 spots leftby Apr 2025
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