Brain Signal Training to Enhance Affect Down-regulation
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
Central Institute of Mental Health, Mannheim
164 participants
Apr 23, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- years
- Diagnosis of Borderline Personality Disorder
- Insufficient response to ≥2 therapies.
- 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
- Ability of subject to understand character and individual consequences of clinical investigation
- Written informed consent (must be available before enrollment in the clinical investigation)
- For women of childbearing potential (WOCBP) adequate contraception.
Exclusion Criteria19
- Treatment with benzodiazepines within 7 days prior the initial screening
- Current alcohol or substance dependence
- Meeting the diagnostic criteria for a psychotic disorder or schizophrenia (life-time), as determined by clinical interview at initial screening
- 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)
- Significant visual impairment that might interfere with the performance of the behavioural tasks or fMRI tasks
- Change of treatment (psychopharmacologic, psychological) 2 weeks prior to or during the study participation
- Treatment with any neurofeedback three months prior to or during the study participation.
- Unable or unwilling to comply with study procedures, including study prohibitions and restrictions
- History of claustrophobia or inability to tolerate scanner environment
- Fulfilling any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants)
- Clinically relevant structural brain abnormality as determined by prior MRI scan
- Planned medical treatment within the study period that might interfere with the study procedures
- Participants deemed to be at significant risk of serious violence or suicide
- BMI of 16.5 or lower
- Participation in other clinical trials or observation period of competing trials, respectively
- Previous participation in this trial
- Pregnancy and lactation
- Held in an institution by legal or official order
- Legally incapacitated.
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Interventions
Real-time fMRI neurofeedback from amygdala's blood oxygenation level dependent (BOLD) signal + negative emotional picture viewing. Instruction to regulate feedback via down-regulation of one's emotional response.
Recorded neurofeedback from a different participant + negative emotional picture viewing. Instruction to regulate feedback via down-regulation of one's emotional response.
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT06626789