Neurofeedback for Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:

Amygdala rtfMRI Neurofeedback for Borderline Personality Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05398627
• Other study ID #: STUDY22040107
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: August 2023
• Source: University of Pittsburgh
• Contact: Kymberly Young, PhD
• Phone: 412-648-6179
• Email: youngk[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• Amygdala Neurofeedback
real-time feedback on the hemodynamic response of the amygdala during positive autobiographical memory recall

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	AE Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline in Beck Depression Inventory at 12 weeks	Assessment of severity of depressive symptoms. This is a 21 item self-report scale with items rated from 0-3 and scores ranging from 0 to 63 with higher scores indicating worse depression. A score less than 13 is considered to be in the healthy range, scores 14-19 indicate mild depression, scores 20-28 indicate moderate depression, scores 29-63 indicate severe depression.	Baseline vs 12 weeks