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

NCT04138680 | Completed

• 2 other identifiers: GCO 19-0616Study-19-00401
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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

Major Depressive Disorder

Keywords

Brain Imaging; Biofeedback

Outcome Measures

Primary Outcomes (1)

• Percent Increase in VTA Activation during MOTIVATE trials

  For each subject, the % increase in VTA activation during MOTIVATE trails at post-training compared to pre-training will be computed (\[MOTIVATEpost\>RESTpost\] \> \[MOTIVATEpre\>RESTpre\]), indicating the efficacy of training on VTA activity self- regulation. This measure of VTA activity self-regulation from pre to post training will be entered into an independent samples t-test to compare between active and control feedback groups.

  baseline (Pre-training) and 2 hours (Post-training) during the assessment visit

Study Arms (2)

Active Biofeedback

EXPERIMENTAL

The patients in the active group will receive one active biofeedback training session.

Behavioral: Active Biofeedback

Sham Biofeedback

SHAM COMPARATOR

The patients in the sham group will receive one sham biofeedback training session.

Behavioral: Sham Biofeedback

Interventions

Active Biofeedback BEHAVIORAL

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.

Active Biofeedback

Sham Biofeedback BEHAVIORAL

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

Sham Biofeedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18-65 years;
• Meets DSM-5 criteria for major depressive disorder (MDD) as determined by the Structured Clinical Interview for DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI); with a current major depressive episode.
• 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.
• Male or female aged 18-65 years;
• Does not meet for any current or past psychiatric diagnoses as defined by DSM-5 criteria as determined by the Structured Clinical Interview for DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI);
• 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.

You may not qualify if:

• Current or history of schizophrenia or other psychotic disorder, neurodevelopmental disorder, or neurocognitive disorder for patients and for healthy control subjects: any current or lifetime psychiatric disorder as determined by the Structured Clinical Interview for DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI);
• Active substance use disorder within the past 6 months;
• Concomitant use of any medication with central nervous system activity within 1 week of scan;
• Positive urine toxicology screen for drugs of abuse at the time of screening;
• Any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;
• Women who are pregnant;
• Any contraindications to MRI, including claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, inability to lie still for 1 hour or more, and inability to fit in the MRI scanner.
• Patients who are currently hospitalized on the inpatient psychiatric units at Mount Sinai Hospital or involuntarily admitted/court ordered.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Laurel Morris, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single-blind sham controlled randomized trial

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: October 9, 2019
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)