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

Yale University3 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Borderline Personality Disorder

Interventions

real time fMRI neurofeedbackBEHAVIORAL

Participants will use real time feedback about their amygdala activity to learn to decrease amygdala activity.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Connecticut Mental Health Center

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline compared to the week after intervention

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: Baseline compared to the week after intervention

Data from ClinicalTrials.gov

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