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

Not Applicable

Completed

• Conditions: Borderline Personality Disorder
• Interventions: Behavioral: real time fMRI neurofeedback

• Registration Number: NCT04306341
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-12
• Study Start: 2020-11-15
• Primary Completion: 2022-10-07
• Study Completion: 2022-10-07
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	real time fMRI neurofeedback	Neurofeedback in conjunction with Dialectical Behavior Therapy

Primary Outcome Measures

Name	Time	Method
Change in Affective Lability	Baseline compared to the week after intervention	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.

Secondary Outcome Measures

Name	Time	Method
Change in Mean Negative Affect	Baseline compared to the week after intervention	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.
Change in Amygdala Regulation	Baseline compared to the week after intervention	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
Change in Borderline Personality Disorder Symptoms	Baseline compared to the week after intervention	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.

Trial Locations

Locations (1)

Connecticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States