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Brain Signal Training to Enhance Affect Down-regulation

Study acronym: BrainSTEADy
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Eligibility criteria expanded, about 3 wordsv8
  2. Primary completion date: Nov 2026 to Dec 2027
    • Study sites: 4 to 6
    • Study completion date: Aug 2027 to Jun 2028
    v7
  3. Start date: Mar 1, 2025 to Apr 23, 2025
    • Primary completion date: Nov 1, 2026 to Nov 2026
    • Study completion date: Aug 1, 2027 to Aug 2027
    • Secondary endpoints: details revised at 2 of 5 entries
    v6
  4. 2 versions Re-verified since Mar 19, 2025, no change to tracked fieldsv4-v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    v3
  6. Start date: Nov 1, 2024 to Mar 1, 2025v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06626789
Lead Sponsor Central Institute of Mental Health, Mannheim
Collaborators: University Medical Center Freiburg, University of Giessen, University Hospital Tuebingen
Conditions
(from sponsor)		 Borderline Personality Disorder
Related terms Borderline Personality Disorder
Enrollment 164 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov