Actively Recruiting
Brain Signal Training to Enhance Affect Down-regulation
Led by Central Institute of Mental Health, Mannheim · Updated on 2026-02-03
164
Participants Needed
6
Research Sites
162 weeks
Total Duration
On this page
Sponsors
C
Central Institute of Mental Health, Mannheim
Lead Sponsor
U
University Medical Center Freiburg
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Brain Signal Training to Enhance Affect Down-regulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 65 years
- Diagnosed with Borderline Personality Disorder
- Insufficient response to at least two therapies
- Sufficient German language skills to give informed consent and complete study tasks
- Able to understand the clinical investigation and its consequences
- Written informed consent provided before enrollment
- For women of childbearing potential, use of adequate contraception
You will not qualify if you...
- Use of benzodiazepines within 7 days before screening
- Current alcohol or substance dependence
- Diagnosis of psychotic disorder or schizophrenia at any time
- Significant neurological conditions such as stroke, brain injury, or multiple sclerosis
- Significant visual impairment interfering with study tasks
- Changes in psychopharmacologic or psychological treatments within 2 weeks prior or during study
- Neurofeedback treatment within 3 months prior or during study
- Unable or unwilling to comply with study procedures
- History of claustrophobia or inability to tolerate MRI scanner
- Any MRI contraindications such as metal implants
- Clinically relevant brain abnormalities on prior MRI
- Planned medical treatments during study interfering with procedures
- Significant risk of serious violence or suicide
- Body mass index (BMI) of 16.5 or lower
- Participation in other clinical or competing trials
- Previous participation in this trial
- Pregnancy or lactation
- Institutionalization by legal or official order
- Legal incapacity
AI-Screening
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Trial Site Locations
Total: 6 locations
1
University clinic Freiburg
Freiburg im Breisgau, Germany, 79104
Actively Recruiting
2
University clinic Giessen
Giessen, Germany, 35392
Actively Recruiting
3
University Clinic Halle (Saale)
Halle, Germany
Not Yet Recruiting
4
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
5
Central Institute of Mental Health
Mannheim, Germany, 68159
Actively Recruiting
6
University Clinic Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
Research Team
C
Christian Paret-Voigt, Dr.
CONTACT
M
Miroslava Hofmanová
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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