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Brain Signal Training to Enhance Affect Down-regulation
Sponsor: Central Institute of Mental Health, Mannheim
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
Conditions
Interventions
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.
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