Study Comparing Amygdala fMRI Neurofeedback Versus Sham Feedback for Reducing Emotional Instability in Borderline Personality Disorder in Adults Aged 18 to 65

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 amygdalas 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.

Brain Signal Training to Enhance Affect Down-regulation