Skip to content

Measuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder

Measuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04306341
Enrollment
3
Registered
2020-03-12
Start date
2020-11-15
Completion date
2022-10-07
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder

Brief 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.

Interventions

Participants will use real time feedback about their amygdala activity to learn to decrease amygdala activity.

Sponsors

AE Foundation
CollaboratorOTHER
Central Institute of Mental Health, Mannheim
CollaboratorOTHER
Yale University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

1. enrolled in YNHH DBT-IOP 2. must meet specific clinical criteria 3. Inclusion in Experimental group requires participants meet standard safety and quality control requirements for MR scanning 4. For female participants, not pregnant and willing to use a reliable method of contraception during the study

Exclusion criteria

1. IQ\<70 2. vision problem not able to be corrected to normal range 3. medication changes w/in one month 4. Lifetime hx of schizophrenia, schizoaffective d/o, bipolar I disorder. 5. illicit substance use within 7 days of MRI scans 6. taking scheduled opiates 7. taking scheduled benzodiazepines 8. taking scheduled anti-histamines 9. history of seizures 10. significant current or past neurologic illness 11. BMI \< 16.5

Design outcomes

Primary

MeasureTime frameDescription
Change in Affective LabilityBaseline compared to the week after interventionThis 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.

Secondary

MeasureTime frameDescription
Change in Mean Negative AffectBaseline compared to the week after interventionThis 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.
Change in Borderline Personality Disorder SymptomsBaseline compared to the week after interventionThis 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.
Change in Amygdala RegulationBaseline compared to the week after interventionChange 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026