Measuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder

This study will test the impacts of real time fMRI neurofeedback in patients with Borderline Personality Disorder. This is a pilot study in a small number of people enrolled in clinical programs at Yale New Haven Hospital.

Study Overview

• Status: Completed
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Behavioral: real time fMRI neurofeedback

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Connecticut Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. enrolled in YNHH DBT-IOP
2. must meet specific clinical criteria
3. Inclusion in Experimental group requires participants meet standard safety and quality control requirements for MR scanning
4. For female participants, not pregnant and willing to use a reliable method of contraception during the study

Exclusion Criteria:

1. IQ<70
2. vision problem not able to be corrected to normal range
3. medication changes w/in one month
4. Lifetime hx of schizophrenia, schizoaffective d/o, bipolar I disorder.
5. illicit substance use within 7 days of MRI scans
6. taking scheduled opiates
7. taking scheduled benzodiazepines
8. taking scheduled anti-histamines
9. history of seizures
10. significant current or past neurologic illness
11. BMI < 16.5

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Neurofeedback in conjunction with Dialectical Behavior Therapy	Behavioral: real time fMRI neurofeedback; Participants will use real time feedback about their amygdala activity to learn to decrease amygdala activity.
No Intervention: Control; Dialectical Behavior Therapy (treatment as usual)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Affective Lability	This outcome will be measured by the change in variance of negative emotions measured using ecologic momentary assessment (EMA: surveys sent to participants by smartphone app) repeatedly over a four-day period at each timepoint. The variance between measurements at each timepoint will be calculated, and compared to the other timepoints. There will be 5 negative emotion items at each timepoint, and a higher score indicates more negative emotion.	Baseline compared to the week after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Negative Affect	This outcome will be measured by change in mean negative emotion score measured using ecologic momentary assessment (EMA: surveys sent to participants by smartphone app) repeatedly over a four-day period at each timepoint. The mean score at each timepoint will be calculated, and compared to the other timepoints. There will be 5 negative emotion items at each timepoint, and a higher score indicates more negative emotion.	Baseline compared to the week after intervention
Change in Borderline Personality Disorder Symptoms	This outcome will be measured by change in Borderline Symptom List (BSL-23) score after neurofeedback. This scale has 23 items, each scored 0-4, and total score is mean item endorsement (sum of all items divided by 23). Higher scores indicate more symptom endorsement.	Baseline compared to the week after intervention
Change in Amygdala Regulation	Change in ability to regulate amygdala activity when exposed to provocative images. Amygdala activity is measured as functional magnetic resonance imaging (fMRI) blood oxygen dependant (BOLD) signal	Baseline compared to the week after intervention

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Central Institute of Mental Health, Mannheim; AE Foundation
• Investigators: Principal Investigator: Sarah K Fineberg, MD PhD, Yale University; Principal Investigator: Michelle Hampson, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Actual): October 7, 2022
• Study Completion (Actual): October 7, 2022

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: 2000026750

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No