Training brain signals to help manage emotions in Borderline Personality Disorder
A Multi-center, Patient-blinded and Investigator-blinded, Randomized, Parallel-group, Superiority Study to Compare the Efficacy of Four Sessions of Amygdala fMRI-BOLD Neurofeedback With Yoked Sham-control Neurofeedback in the Treatment of Dysregulated Affect in Borderline Personality Disorder
This study is testing if training brain signals can help people with Borderline Personality Disorder manage their emotions better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Central Institute of Mental Health, Mannheim Academic / other |
| Locations | 6 sites (Freiburg im Breisgau and 5 other locations) |
| Trial ID | NCT06626789 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of neurofeedback training targeting the amygdala to help individuals with Borderline Personality Disorder (BPD) better regulate their emotions. Using functional magnetic resonance imaging (fMRI), participants will receive real-time feedback on their brain activity, specifically focusing on reducing hyperactivity in the amygdala, which is linked to emotional instability. The study will involve 164 patients across four centers, assessing changes in emotional regulation before and after the intervention. The goal is to determine if this targeted neurofeedback can lead to significant improvements in managing affective instability.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of Borderline Personality Disorder who have not responded adequately to at least two previous therapies.
Not a fit: Patients with current substance dependence, psychotic disorders, or significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide patients with BPD a novel method to gain control over their emotional responses, potentially reducing symptoms and improving quality of life.
How similar studies have performed: While neurofeedback has shown promise in other studies for various conditions, this specific approach targeting the amygdala in BPD is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Freiburg im Breisgau and 5 other locations
- University clinic Freiburg — Freiburg im Breisgau, Germany (Recruiting)
- University clinic Giessen — Giessen, Germany (Recruiting)
- University Clinic Halle (Saale) — Halle, Germany (Not_yet_recruiting)
- University Medical Center Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
- Central Institute of Mental Health — Mannheim, Germany (Recruiting)
- University Clinic Tuebingen — Tübingen, Germany (Recruiting)
Study contacts
- Principal investigator: Christian Paret-Voigt, Dr. — ZI Mannheim
- Study coordinator: Christian Paret-Voigt, Dr.
- Email: christian.paret@zi-mannheim.de
- Phone: +4962117034462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.