Clinical Trial

Brain Signal Training to Enhance Affect Down-regulation

Study acronym: BrainSTEADy
Recruiting Phase 1/2
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-10-01; most recent amendment 2026-01-30.
Status change: Not Yet Recruiting → Recruiting 2025-03-10
Trial Details
NCT Number NCT06626789
Lead Sponsor Central Institute of Mental Health, Mannheim
Collaborators: University Medical Center Freiburg, University of Giessen, University Hospital Tuebingen
Conditions Borderline Personality Disorder
Enrollment 164 participants
Start Date 2025-04-23
Primary Completion 2027-12 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-02-03