RECRUITING

Network Neurofeedback Using 7-Tesla MRI to Reduce Rumination Levels in Depression

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Patients with major depressive disorder (MDD) exhibit increased levels of rumination (i.e. repetitive thinking and focus on negative mood states) which have been found to increase the risk of depressive relapse. The ability to reduce rumination levels among these patients is greatly needed. Rumination is known to be associated with the default mode network (DMN) region activity. Implementing the Dependency Network Analysis (DEPNA), a recently developed method by the research team to quantify the connectivity influence of network nodes, found that rumination was significantly associated with lower connectivity influence of the left medial orbitofrontal cortex (MOFC) on the right precuneus, both key regions within the DMN. This study implements the first real-time fMRI neurofeedback (Rt-fMRI-NF) network-based protocol for up-regulation of the MOFC influence on the precuneus in patients with MDD to reduce rumination levels. This will allow for more accurate explicit brain connections modulation than the standard single brain region activity; creating a larger opportunity for target clinical neuromodulation treatment in individuals with MDD.

Official Title

Network-based Real-time Neurofeedback Using Ultra-high Field MRI to Reduce Rumination Levels in Depression

Quick Facts

Study Start:2023-07-12
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05933148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female aged 18-65 years who either meet DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI) for major depressive disorder (MDD) with a current major depressive episode OR does not meet for any current or past psychiatric diagnoses
  2. * Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process
  1. * Any current or history of schizophrenia or other psychotic disorder, neurodevelopmental disorder, or neurocognitive disorder for patients, active substance use disorder within the past 6 months
  2. * Unstable medical illness, concomitant use of any medication with central nervous system activity within 1 week of MRI scan
  3. * Pregnancy
  4. * Patients who are currently hospitalized in the inpatient psychiatric units at Mount Sinai Hospital or involuntarily admitted/court-ordered
  5. * Subjects judged to be at serious and imminent suicidal or homicidal risk by the study-affiliated psychiatrist or another MD, and contradictions to MRI

Contacts and Locations

Study Contact

Grace S. Butler, BA
CONTACT
(212) 585-4623
grace.butler@mssm.edu
Rachel Krasner, BA
CONTACT
rachel.krasner@mssm.edu

Principal Investigator

Yael Jacob, PhD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School Of Medicine at Mount Sinai
New York City, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Yael Jacob, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-12
Study Completion Date2027-04

Study Record Updates

Study Start Date2023-07-12
Study Completion Date2027-04

Terms related to this study

Additional Relevant MeSH Terms

  • Major Depressive Disorder