Neurofeedback for Borderline Personality Disorder

NCT05398627 | Completed FDA Device

• 1 other identifier: STUDY22040107
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Keywords

fMRI neurofeedback; amygdala

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Borderline Scale from the Personality Assessment Inventory at 12 weeks

  Assessment of severity of borderline symptoms. This scale contains 24 items rated on a four-point scale (0=false to 3=very true). Scores range from 0-72, and are converted to T scores, with higher scores indicating more borderline symptoms. Scores below 59 indicate healthy, scores at or above 70T indicate the respondent is likely to have borderline personality disorder.

  Baseline vs 12 weeks

Secondary Outcomes (1)

• Change from Baseline in Beck Depression Inventory at 12 weeks

  Baseline vs 12 weeks

Study Arms (1)

Amygdala Neurofeedback

EXPERIMENTAL

Participants will undergo real-time fMRI neurofeedback training to increase their amygdala response while recalling positive autobiographical memories. 2 sessions will occur within a one week period.

Device: Amygdala Neurofeedback

Interventions

Amygdala Neurofeedback DEVICE

real-time feedback on the hemodynamic response of the amygdala during positive autobiographical memory recall

Amygdala Neurofeedback

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 currently pregnant or breast feeding
• are unable to complete questionnaires written in English
• have a DSM-5 diagnosis of psychotic or organic mental disorder
• have any eye problems or difficulties in corrected vision.
• Serious suidicial ideation

Sponsors & Collaborators

• Kymberly Young: lead
• AE Foundation: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Kymberl Young, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 1, 2022
• Study Start: September 2, 2022
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)