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RECRUITING
NCT06626789
PHASE1/PHASE2

Brain Signal Training to Enhance Affect Down-regulation

Sponsor: Central Institute of Mental Health, Mannheim

View on ClinicalTrials.gov

Summary

Individuals with Borderline Personality Disorder (BPD) experience intensive, instable negative emotions. Hyperactivity of the amygdala is assumed to drive exaggerated emotional responses in BPD. Neurofeedback is an endogenous neuromodulation method to address the imbalance of neural circuits. Downregulation of amygdala hyperactivation with neurofeedback may ameliorate dysregulated emotions in BPD. The BrainSTEADy trial is designed to determine whether amygdala-fMRI-BOLD neurofeedback has a specific effect on affect instability in BPD beyond nonspecific benefit.

Official title: A Multi-center, Patient-blinded and Investigator-blinded, Randomized, Parallel-group, Superiority Study to Compare the Efficacy of Four Sessions of Amygdala fMRI-BOLD Neurofeedback With Yoked Sham-control Neurofeedback in the Treatment of Dysregulated Affect in Borderline Personality Disorder

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

164

Start Date

2025-04-23

Completion Date

2028-06

Last Updated

2026-02-03

Healthy Volunteers

No

Interventions

BIOLOGICAL

Amygdala neurofeedback

Real-time fMRI neurofeedback from amygdala's blood oxygenation level dependent (BOLD) signal + negative emotional picture viewing. Instruction to regulate feedback via down-regulation of one's emotional response.

BEHAVIORAL

Sham neurofeedback

Recorded neurofeedback from a different participant + negative emotional picture viewing. Instruction to regulate feedback via down-regulation of one's emotional response.

Locations (6)

University clinic Freiburg

Freiburg im Breisgau, Germany

University clinic Giessen

Giessen, Germany

University Clinic Halle (Saale)

Halle, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Central Institute of Mental Health

Mannheim, Germany

University Clinic Tuebingen

Tübingen, Germany