About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis of Borderline Personality Disorder
Insufficient response to ≥2 therapies.
Sufficient German language skills to give informed consent to the study, to understand questions posed by used instruments, and capable of completing the fMRI tasks
Ability of subject to understand character and individual consequences of clinical investigation
Disqualifiers
Treatment with benzodiazepines within 7 days prior the initial screening
Current alcohol or substance dependence
Meeting the diagnostic criteria for a psychotic disorder or schizophrenia (life-time), as determined by clinical interview at initial screening
Current or history of significant neurological condition (such as stroke, traumatic brain injury, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack)
Trial design
Treatments tested in this trial
- Amygdala neurofeedback
- Sham neurofeedback
Treatment groups
Sponsors and collaborators
Central Institute of Mental Health, Mannheim
Lead sponsor
University Medical Center Freiburg
Collaborator
University of Giessen
Collaborator
University Hospital Tuebingen
Collaborator