Clinical trial NCT05398627: Neurofeedback for Borderline Personality Disorder
Official title: Amygdala RtfMRI Neurofeedback for Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: fMRI neurofeedback
amygdala
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: AE Foundation
First posted: 2022-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate whether rtfMRI-nf training to increase the amygdala response to positive memories may serve as an intervention for borderline personality disorder.

Detailed description: We will assess the treatment effects of real-time fMRI neurofeedback in adults with borderline personality disorder. This is an experimental longitudinal design where participants will be followed every two weeks after receiving 2 sessions of neurofeedback from the amygdala . Procedures involve a battery of self-report measures, fMRI and psychophysiological indices (heart rate, respiration).

Eligibility criteria: Inclusion Criteria:

* right-handed adults (ages 18 - 55) with a primary diagnosis of Borderline Personality Disorder according to diagnostic criteria in the Structured Interview for DSM Personality Disorders
* must be able to give written informed consent prior to participation
* unmedicated or stable on an SSRI antidepressant regime (at least 3 weeks to ensure symptoms are stable)
* English speaking

Exclusion Criteria:

* have a clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
* Current moderate or severe DSM-V alcohol or substance use disorder, with the exception of nicotine or caffeine. Clinician will access subjects' alcohol and substance use on a case-by-case to determine whether specific cases of mild alcohol or substance use would also interfere with the effects of the intervention.
* have a history of traumatic brain injury
* are unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
* are currently pregnant or breast feeding
* are unable to complete questionnaires written in English
* current (within 3 weeks of testing) use of any antipsychotics, benzodiazepines, beta-blockers, or other medications (except SSRI antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study. Inclusion of patients on stable antidepressant medications was decided in order to allow generalization towards a real world population
* have a DSM-5 diagnosis of psychotic or organic mental disorder
* have any eye problems or difficulties in corrected vision.
* Serious suidicial ideation

Primary outcomes:
measure: Change from Baseline in Borderline Scale from the Personality Assessment Inventory at 12 weeks
timeFrame: Baseline vs 12 weeks
Secondary outcomes:
measure: Change from Baseline in Beck Depression Inventory at 12 weeks
timeFrame: Baseline vs 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Kymberl Young, PhD
role: PRINCIPAL_INVESTIGATOR
References: