- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05398627
Neurofeedback for Borderline Personality Disorder
May 4, 2026 updated by: Kymberly Young
Amygdala rtfMRI Neurofeedback for Borderline Personality Disorder
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Amygdala Neurofeedback
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.
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real-time feedback on the hemodynamic response of the amygdala during positive autobiographical memory recall
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Borderline Scale from the Personality Assessment Inventory at 12 weeks
Time Frame: Baseline vs 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Beck Depression Inventory at 12 weeks
Time Frame: Baseline vs 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.
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Baseline vs 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kymberl Young, PhD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 2, 2022
Primary Completion (Actual)
April 30, 2026
Study Completion (Actual)
April 30, 2026
Study Registration Dates
First Submitted
May 25, 2022
First Submitted That Met QC Criteria
May 25, 2022
First Posted (Actual)
June 1, 2022
Study Record Updates
Last Update Posted (Actual)
May 5, 2026
Last Update Submitted That Met QC Criteria
May 4, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY22040107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified data will be made available to researchers who sign a data sharing agreement with the PI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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