Training brain signals to help manage emotions in Borderline Personality Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 study participation or before completion of the post-assessment.
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 it's running

• University clinic Freiburg
  Freiburg im Breisgau, Germany Recruiting
• University clinic Giessen
  Giessen, Germany Recruiting
• University Medical Center Hamburg-Eppendorf
  Hamburg, Germany Recruiting
• Central Institute of Mental Health
  Mannheim, Germany Recruiting
• University Clinic Tuebingen
  Tübingen, Germany Recruiting
• University Clinic Halle (Saale)
  Halle, Germany Not yet 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Training to improve emotion regulation in people with Borderline Personality Disorder

  This study is testing a new training program to help people with Borderline Personality Disorder learn better ways to manage their emotions.

  Recruiting Icahn School of Medicine at Mount Sinai · New York, New York · NCT06772831

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.