Brain Signal Training to Enhance Affect Down-regulation

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentral Institute of Mental Health, Mannheim

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

164 Participants
are divided into 2 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