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Real-time Biofeedback With 7-Tesla MRI for Treatment of Depression

NCT04138680 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2024-09-04

No results posted yet for this study

Summary

Previous research has shown that modulation of a brain region in rodents, the ventral tegmental area (VTA), improves depressive symptoms. Human research has also shown that VTA self-modulation using 'biofeedback' is feasible and successful in healthy volunteers. This biofeedback procedure is a type of cognitive training that includes real-time feedback about brain signal levels from the VTA. Our question is whether VTA self-modulation with biofeedback can influence depression symptoms.

Conditions

Interventions

BEHAVIORAL

Active Biofeedback

The active biofeedback session will be done within the 7T MRI. It will include a pre-training run, 3 training runs, and a post-training run. Each run will be comprised of MOTIVATE and REST trials. During each MOTIVATE trial, subjects will be instructed to "generate a heightened state of motivation". Participants will be encouraged to identify strategies that are personally relevant or useful and to monitor the efficacy of the strategies. Subjects will simultaneously view a progress bar on the screen during MOTIVATE trials that represents their VTA activity and they will be trained to try to increase the level of the bar by motivating themselves. For the active VTA biofeedback group, the progress bar will be updated every second to accurately convey level of VTA signal activation. During REST trials, all subjects will be instructed to count backwards. During the post-training 'test' run, subjects will be instructed to use the strategies they found to be most effective.

BEHAVIORAL

Sham Biofeedback

The sham biofeedback session resembles the active condition, however, the thermometer seen during the MOTIVATE trials will represent yoked sham values.

Sponsors & Collaborators

Principal Investigators

  • Laurel Morris, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-09
Primary Completion
2024-06-11
Completion
2024-06-11

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04138680 on ClinicalTrials.gov