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Completed

NCT Number: NCT04306341

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.

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Key information

Conditions

Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Real Time fMRI Neurofeedback

Behavioral

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

Primary outcomes

  1. Change in Affective Lability

    Time frame: 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 outcomes

  1. Change in Mean Negative Affect

    Time frame: 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.

  2. Change in Borderline Personality Disorder Symptoms

    Time frame: 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.

  3. Change in Amygdala Regulation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • AE Foundation
  • Central Institute of Mental Health, Mannheim

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 12, 2020
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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