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New treatment option for Borderline Personality Disorder
Official title Brain Signal Training to Enhance Affect Down-regulation
ClinicalTrials.gov ID: NCT06626789
What this study is testing
What is Amygdala neurofeedback?
Amygdala neurofeedback is an investigational medicine, being studied as a potential treatment for borderline personality disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Individuals with Borderline Personality Disorder (BPD) experience intensive, instable negative emotions. Hyperactivity of the amygdala is assumed to drive exaggerated emotional responses in BPD.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Stage 1: 82 patients, stage 2: 82 patients 1. 18-65 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...
- Ability of subject to understand character and individual consequences of clinical investigation
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- Stage 1: 82 patients, stage 2: 82 patients 1. 18-65 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Freiburg im Breisgau, Germany
- Giessen, Germany
- Halle, Germany
- Hamburg, Germany
- Mannheim, Germany
- Tübingen, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Freiburg im Breisgau, Germany; Giessen, Germany; Halle, Germany; Hamburg, Germany; Mannheim, Germany; Tübingen, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.