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

Borderline Personality Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04306341
• Other study ID #: 2000026750
• Status: Completed
• Phase: N/A
• Start date: November 15, 2020
• Est. completion date: October 7, 2022

Study information

• Verified date: May 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: October 7, 2022
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• real time fMRI neurofeedback
Participants will use real time feedback about their amygdala activity to learn to decrease amygdala activity.

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	AE Foundation, Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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