NCT06626789 Brain Signal Training to Enhance Affect Down-regulation
| NCT ID | NCT06626789 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Central Institute of Mental Health, Mannheim |
| Condition | Borderline Personality Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2025-04-23 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 164 participants in total. It began in 2025-04-23 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Christian Paret-Voigt, Dr.
PRINCIPAL INVESTIGATOR
ZI Mannheim
Frequently Asked Questions
Who can join the NCT06626789 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Borderline Personality Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06626789 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06626789 currently recruiting?
Yes, NCT06626789 is actively recruiting participants. Contact the research team at christian.paret@zi-mannheim.de for enrollment information.
Where is the NCT06626789 trial being conducted?
This trial is being conducted at Freiburg im Breisgau, Germany, Giessen, Germany, Halle, Germany, Hamburg, Germany and 2 additional locations.
Who is sponsoring the NCT06626789 clinical trial?
NCT06626789 is sponsored by Central Institute of Mental Health, Mannheim. The principal investigator is Christian Paret-Voigt, Dr. at ZI Mannheim. The trial plans to enroll 164 participants.