Borderline Personality DisorderNCT05398627
Neurofeedback for Borderline Personality Disorder
A study testing Amygdala Neurofeedback in people with Borderline Personality Disorder, run by Kymberly Young at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Amygdala Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2022to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the 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).
- Conditions
- Borderline Personality Disorder
- Being tested
- Amygdala Neurofeedback
- Keywords
- fMRI neurofeedback, amygdala
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amygdala NeurofeedbackDevice
real-time feedback on the hemodynamic response of the amygdala during positive autobiographical memory recall
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Amygdala Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline vs 12 weeks
Secondary outcomes (1)
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.
Measured: Baseline vs 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start2 Sep 2022
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kymberly Young
- Sponsor type
- University, hospital or other
- Collaborators
- AE Foundation
- Responsible party
- Sponsor-investigator, Kymberly Young, University of Pittsburgh
- Investigators
- Kymberl Young, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398627
- Sponsor's protocol ID
- STUDY22040107
- Status last verified
- May 2026
- First submitted
- 25 May 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified data will be made available to researchers who sign a data sharing agreement with the PI
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amygdala rtfMRI Neurofeedback for Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT05398627
- Acronym / sponsor ID
- STUDY22040107
- Conditions
- Borderline Personality Disorder
- Keywords
- fMRI neurofeedback, amygdala
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kymberly YoungUniversity, hospital or other
- Collaborators
- AE Foundation
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amygdala Neurofeedback | Experimental | Device: Amygdala NeurofeedbackParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amygdala Neurofeedbackreal-time feedback on the hemodynamic response of the amygdala during positive autobiographical memory recall | Device | Amygdala Neurofeedback |
Primary outcome
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.
1 secondary outcome
Change from Baseline in Beck Depression Inventory at 12 weeks
Time frame: Baseline vs 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be made available to researchers who sign a data sharing agreement with the PI
Related trials for Borderline Personality Disorder
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Effectiveness of Enhanced Dialectical Behavior Therapy Skills Training Group for Borderline Personality Disorder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kymberl Young, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amygdala Neurofeedback in people with Borderline Personality Disorder, run by Kymberly Young at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Borderline Scale from the Personality Assessment Inventory at 12 weeks (time frame: Baseline vs 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.