Brain Signal Training to Enhance Affect Down-regulation

Launched by CENTRAL INSTITUTE OF MENTAL HEALTH, MANNHEIM · Oct 1, 2024

Keywords

ClinConnect Summary

The BrainSTEADy trial is studying a new way to help people with Borderline Personality Disorder (BPD) manage their intense emotions. Many individuals with BPD have strong feelings that can change quickly, often due to heightened activity in a part of the brain called the amygdala, which is responsible for processing emotions. This trial is testing a method called neurofeedback, which uses brain imaging to help participants learn to regulate their amygdala activity. The goal is to see if this training can help reduce emotional instability in people with BPD more effectively than other treatments.

To be eligible for this study, participants need to be between 18 and 65 years old and have a diagnosis of BPD that hasn't improved with at least two previous therapies. They also need to be able to understand and communicate in German and give their written consent to join the study. The trial is currently recruiting participants, and those who join can expect to engage in brain imaging tasks while receiving feedback about their brain activity. It's important to note that individuals with certain medical conditions or those who have recently undergone specific treatments may not be eligible. This study offers a promising opportunity for individuals seeking new ways to manage their emotions effectively.

Gender

ALL

Eligibility criteria

• • Stage 1: 82 patients, stage 2: 82 patients Inclusion Criteria
• • 1. 18-65 years
• • 2. Diagnosis of Borderline Personality Disorder
• • 3. Insufficient response to ≥2 therapies.
• • 4. 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
• • 5. Ability of subject to understand character and individual consequences of clinical investigation
• • 6. Written informed consent (must be available before enrollment in the clinical investigation)
• • 7. For women of childbearing potential (WOCBP) adequate contraception.
• • Exclusion Criteria
• • 1. Treatment with benzodiazepines within 7 days prior the initial screening
• • 2. Current alcohol or substance dependence
• • 3. Meeting the diagnostic criteria for a psychotic disorder or schizophrenia (life-time), as determined by clinical interview at initial screening
• • 4. 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)
• • 5. Significant visual impairment that might interfere with the performance of the behavioural tasks or fMRI tasks
• • 6. Change of treatment (psychopharmacologic, psychological) 2 weeks prior to or during the study participation
• • 7. Treatment with any neurofeedback three months prior to or during the study participation.
• • 8. Unable or unwilling to comply with study procedures, including study prohibitions and restrictions
• • 9. History of claustrophobia or inability to tolerate scanner environment
• • 10. Fulfilling any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants)
• • 11. Clinically relevant structural brain abnormality as determined by prior MRI scan
• • 12. Planned medical treatment within the study period that might interfere with the study procedures
• • 13. Participants deemed to be at significant risk of serious violence or suicide
• • 14. BMI of 16.5 or lower
• • 15. Participation in other clinical trials or observation period of competing trials, respectively
• • 16. Previous participation in this trial
• • 17. Pregnancy and lactation
• • 18. Held in an institution by legal or official order
• • 19. Legally incapacitated.