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Clinical Trials/NCT04306341
NCT04306341
Completed
Not Applicable

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

Yale University1 site in 1 country3 target enrollmentNovember 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Borderline Personality Disorder
Sponsor
Yale University
Enrollment
3
Locations
1
Primary Endpoint
Change in Affective Lability
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2020
End Date
October 7, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • 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

Outcomes

Primary Outcomes

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

  • Change in Mean Negative Affect(Baseline compared to the week after intervention)
  • Change in Amygdala Regulation(Baseline compared to the week after intervention)
  • Change in Borderline Personality Disorder Symptoms(Baseline compared to the week after intervention)

Study Sites (1)

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