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

NCT ID: NCT04306341

Last Updated: 2023-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2022-10-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Borderline Personality Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

Neurofeedback in conjunction with Dialectical Behavior Therapy

Group Type EXPERIMENTAL

real time fMRI neurofeedback

Intervention Type BEHAVIORAL

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

Control

Dialectical Behavior Therapy (treatment as usual)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

real time fMRI neurofeedback

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AE Foundation

OTHER

Sponsor Role collaborator

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sarah K Fineberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Michelle Hampson, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Connecticut Mental Health Center

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2000026750

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

fMRI in Impulsivity
NCT02755181 COMPLETED
Neurofeedback to Treat Depression
NCT05169346 COMPLETED NA
Neurofeedback to Treat Depression - 2
NCT07159061 RECRUITING NA