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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)
Secondary outcome measures
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
862 Previous Clinical Trials
525,546 Total Patients Enrolled
35 Trials studying Depression
4,369 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there enrollment opportunities available for this research endeavor?

"According to the details published on clinicaltrials.gov, this research project is still open for patient recruitment. This trial was initially posted on July 1st 2023 and recently updated on July 5th 2023."

Answered by AI

Is this investigation accommodating individuals of advanced age?

"As per the study's qualifications, participants must be aged 18 to 65 years old. Additionally, there are 120 trails for minors and 620 trials for those over the age of retirement."

Answered by AI

How many volunteers have enrolled in this experiment?

"Affirmative. The information available on clinicaltrials.gov reveals that this study is actively seeking participants, which was first made public on July 1st 2023 and most recently amended on the 5th of July 2023. A total of 80 individuals need to be recruited for the trial at one particular location."

Answered by AI

What criteria must a participant meet to be involved in this research?

"To take part in this clinical trial, participants must meet criteria such as being between 18 and 65 years of age and have a diagnosis of depression. 80 individuals are slated to be included the study."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
New York
What site did they apply to?
Icahn School Of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've tried SSRIs and CBT with mild success but no lasting relief. I'm deeply interested in how devices will impact mental health treatment.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Icahn School Of Medicine at Mount Sinai: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Network Neurofeedback Using 7-Tesla MRI to Reduce Rumination Levels in Depression
Yael Jacob 2023. "Network Neurofeedback Using 7-Tesla MRI to Reduce Rumination Levels in Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05933148.
All > Depression New York
~44 spots leftby May 2025
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