Borderline Personality DisorderNCT04306341
Measuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder
A study testing real time fMRI neurofeedback in people with Borderline Personality Disorder, run by Yale University at 1 site in United States.
Trial summary
This study will test the impacts of real time fMRI neurofeedback in patients with Borderline Personality Disorder. This is a pilot study in a small number of people enrolled in clinical programs at Yale New Haven Hospital. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- real time fMRI neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2020to 7 Oct 2022
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- enrolled in YNHH DBT-IOP
- must meet specific clinical criteria
- Inclusion in Experimental group requires participants meet standard safety and quality control requirements for MR scanning
- For female participants, not pregnant and willing to use a reliable method of contraception during the study
Who cannot join
- IQ<70
- vision problem not able to be corrected to normal range
- medication changes w/in one month
- Lifetime hx of schizophrenia, schizoaffective d/o, bipolar I disorder.
- illicit substance use within 7 days of MRI scans
- taking scheduled opiates
Show all 11Show fewer
- taking scheduled benzodiazepines
- taking scheduled anti-histamines
- history of seizures
- significant current or past neurologic illness
- BMI < 16.5
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
This study will test the impacts of real time fMRI neurofeedback in patients with Borderline Personality Disorder. This is a pilot study in a small number of people enrolled in clinical programs at Yale New Haven Hospital.
- Conditions
- Borderline Personality Disorder
- Being tested
- real time fMRI neurofeedback
- 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.
real time fMRI neurofeedbackBehavioural
Participants will use real time feedback about their amygdala activity to learn to decrease amygdala activity.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Neurofeedback in conjunction with Dialectical Behavior Therapy Receives: Behavioral: real time fMRI neurofeedback |
| Control | No intervention | Dialectical Behavior Therapy (treatment as usual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Affective Lability
This outcome will be measured by the change in variance of negative emotions measured using ecologic momentary assessment (EMA: surveys sent to participants by smartphone app) repeatedly over a four-day period at each timepoint. The variance between measurements at each timepoint will be calculated, and compared to the other timepoints. There will be 5 negative emotion items at each timepoint, and a higher score indicates more negative emotion.
Measured: Baseline compared to the week after intervention
Secondary outcomes (3)
Change in Mean Negative Affect
This outcome will be measured by change in mean negative emotion score measured using ecologic momentary assessment (EMA: surveys sent to participants by smartphone app) repeatedly over a four-day period at each timepoint. The mean score at each timepoint will be calculated, and compared to the other timepoints. There will be 5 negative emotion items at each timepoint, and a higher score indicates more negative emotion.
Measured: Baseline compared to the week after intervention
Change in Borderline Personality Disorder Symptoms
This outcome will be measured by change in Borderline Symptom List (BSL-23) score after neurofeedback. This scale has 23 items, each scored 0-4, and total score is mean item endorsement (sum of all items divided by 23). Higher scores indicate more symptom endorsement.
Measured: Baseline compared to the week after intervention
Change in Amygdala Regulation
Change in ability to regulate amygdala activity when exposed to provocative images. Amygdala activity is measured as functional magnetic resonance imaging (fMRI) blood oxygen dependant (BOLD) signal
Measured: Baseline compared to the week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start15 Nov 2020
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
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.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- AE Foundation, Central Institute of Mental Health, Mannheim
- Responsible party
- Sponsor
- Investigators
- Sarah K Fineberg, MD PhD, Principal investigator, Yale UniversityMichelle Hampson, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306341
- Sponsor's protocol ID
- 2000026750
- Status last verified
- May 2023
- First submitted
- 10 Mar 2020
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT04306341
- Acronym / sponsor ID
- 2000026750
- Conditions
- Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- AE Foundation, Central Institute of Mental Health, Mannheim
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 12 Mar 2020 (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.
This study will test the impacts of real time fMRI neurofeedback in patients with Borderline Personality Disorder. This is a pilot study in a small number of people enrolled in clinical programs at Yale New Haven Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: real time fMRI neurofeedbackNeurofeedback in conjunction with Dialectical Behavior Therapy |
| Control | No intervention | –Dialectical Behavior Therapy (treatment as usual) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- enrolled in YNHH DBT-IOP
- must meet specific clinical criteria
- Inclusion in Experimental group requires participants meet standard safety and quality control requirements for MR scanning
- For female participants, not pregnant and willing to use a reliable method of contraception during the study
Key exclusion criteria (11 listed)
- IQ<70
- vision problem not able to be corrected to normal range
- medication changes w/in one month
- Lifetime hx of schizophrenia, schizoaffective d/o, bipolar I disorder.
- illicit substance use within 7 days of MRI scans
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 |
|---|---|---|
| real time fMRI neurofeedbackParticipants will use real time feedback about their amygdala activity to learn to decrease amygdala activity. | Behavioural | Experimental |
Primary outcome
Change in Affective Lability
Time frame: Baseline compared to the week after intervention
This outcome will be measured by the change in variance of negative emotions measured using ecologic momentary assessment (EMA: surveys sent to participants by smartphone app) repeatedly over a four-day period at each timepoint. The variance between measurements at each timepoint will be calculated, and compared to the other timepoints. There will be 5 negative emotion items at each timepoint, and a higher score indicates more negative emotion.
3 secondary outcomes
Change in Mean Negative Affect
Time frame: Baseline compared to the week after intervention
Change in Borderline Personality Disorder Symptoms
Time frame: Baseline compared to the week after intervention
Change in Amygdala Regulation
Time frame: Baseline compared to the week after intervention
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 22 May 2023.
- Individual participant dataSharing planned: No
Related trials for Borderline Personality Disorder
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Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder
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Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder
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MDMA in Borderline Personality Disorder
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Active, not recruitingPhase 2
Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
Borderline Personality Disorder
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.
Sarah K Fineberg, MD PhD principal investigator
Yale University
Michelle Hampson, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real time fMRI neurofeedback in people with Borderline Personality Disorder, run by Yale University 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 11 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 22 May 2023. 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 in Affective Lability (time frame: Baseline compared to the week after intervention). 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 22 May 2023.