Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder.
Jenny Zaehringer, Gabriele Ende, Philip Santangelo...
https://pubmed.ncbi.nlm.nih.gov/31795041Actively Recruiting
Phase 1
Phase 2
Age: 18Years - 65Years
All Genders
ID06626789
A Multi-center, Patient-blinded and Investigator-blinded, Randomized, Parallel-group Study Comparing Four Sessions of Amygdala fMRI-BOLD Neurofeedback to Sham Control in Treating Dysregulated Affect in Borderline Personality Disorder
Led by Central Institute of Mental Health, Mannheim · Updated on 2026-02-03
164
Participants Needed
6
Research Sites
26 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
Borderline Personality Disorder (BPD) is a mental health condition marked by intense and unstable emotions, including self-harm and severe interpersonal difficulties. This trial investigates whether amygdala-focused neurofeedback, a technique to regulate brain activity, can specifically reduce emotional instability in BPD beyond general benefits. The study involves multiple centers and uses brain imaging to target the amygdala, which is involved in emotional responses, aiming to improve emotion regulation in patients. Participants will undergo four sessions of neurofeedback training where real-time fMRI measures the amygdala's activity as they view negative emotional images. They receive feedback displayed as a thermometer showing amygdala activation levels and are taught to lower this activation. A control group receives sham feedback unrelated to their own amygdala activity. The study includes an interim analysis after enrolling 82 patients, with a total of 164 planned participants across four centers. Throughout the study, patients will complete assessments before, immediately after, and up to six months following the neurofeedback sessions. These include ambulatory evaluations of emotional intensity and symptom severity, brain imaging to measure amygdala response and self-regulation, and quality of life questionnaires. The trial uses detailed monitoring to measure changes in affective instability and aims to understand the clinical effects of this neurofeedback approach in BPD over time.
CONDITIONS
Brief Title
Brain Signal Training to Enhance Affect Down-regulation
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years
- Diagnosed with Borderline Personality Disorder
- Insufficient response to at least two therapies
- Sufficient German language skills to provide informed consent and complete study tasks
- Ability to understand the study and its individual consequences
- Provided written informed consent prior to enrollment
- Women of childbearing potential must use adequate contraception
You will not qualify if you...
- Treatment with benzodiazepines within 7 days before initial screening
- Current alcohol or substance dependence
- Diagnosis of psychotic disorder or schizophrenia at any time
- Significant neurological conditions (e.g., stroke, brain injury, multiple sclerosis, Parkinson's disease)
- Significant visual impairment affecting task performance
- Change in psychopharmacologic or psychological treatment within 2 weeks before or during study
- Neurofeedback treatment within 3 months before or during study
- Unable or unwilling to follow study procedures and restrictions
- History of claustrophobia or inability to tolerate MRI scanner
- MRI contraindications such as metal implants
- Clinically relevant structural brain abnormalities
- Planned medical treatments interfering with study
- High risk of serious violence or suicide
- Body Mass Index (BMI) of 16.5 or lower
- Participation in other clinical or observational trials
- Previous participation in this trial
- Pregnancy or lactation
- Institutionalization by legal or official order
- Legal incapacity or guardianship status
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 4 weeks
Participants undergo four neurofeedback training sessions using fMRI to learn to regulate their amygdala response.
4 visits (in-person)
Follow-up
Duration - Up to 6 months
Participants are monitored after the treatment to assess changes in affective instability and quality of life.
Assessments within 1 week, 14 to 16 weeks, and 6 months after last treatment session
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
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Research Team
C
Christian Paret-Voigt, Dr.
M
Miroslava Hofmanová
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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Published Research Related To This Trial
Alterations of amygdala-prefrontal connectivity with real-time fMRI neurofeedback in BPD patients.
Christian Paret, Rosemarie Kluetsch, Jenny Zaehringer...
https://pubmed.ncbi.nlm.nih.gov/26833918Down-regulation of amygdala activation with real-time fMRI neurofeedback in a healthy female sample.
Christian Paret, Rosemarie Kluetsch, Matthias Ruf...
https://pubmed.ncbi.nlm.nih.gov/25278851A randomised controlled trial of amygdala fMRI-neurofeedback versus sham-feedback in borderline-personality disorder - systematic literature review and introduction to the BrainSTEADy trial.
Christian Paret, Miroslava Jindrová, Nikolaus Kleindienst...
https://pubmed.ncbi.nlm.nih.gov/40629288