Brain Signal Training to Enhance Affect Down-regulation

Who cannot take part

• Treatment with benzodiazepines within 7 days prior the initial screening
• Change of treatment (psychopharmacologic, psychological) 2 weeks prior to study participation or before completion of the post-assessment
• Treatment with any neurofeedback three months prior to or during the study participation
• Clinically relevant structural brain abnormality as determined by prior MRI scan
• Previous participation in this trial
• 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)
• Significant visual impairment that might interfere with the performance of the behavioural tasks or fMRI tasks
• History of claustrophobia or inability to tolerate scanner environment
• Fulfilling any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants)
• Current alcohol or substance dependence
• Unable or unwilling to comply with study procedures, including study prohibitions and restrictions
• Planned medical treatment within the study period that might interfere with the study procedures
• Participants deemed to be at significant risk of serious violence or suicide
• BMI of 16.5 or lower
• Participation in other clinical trials or observation period of competing trials, respectively
• Pregnancy and lactation
• Held in an institution by legal or official order
• Legally incapacitated

Other criteria

• Stage 1: 82 patients, stage 2: 82 patients Inclusion Criteria
• 18-65 years
• 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
• Written informed consent (must be available before enrollment in the clinical investigation)
• For women of childbearing potential (WOCBP) adequate contraception