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Brain Signal Training to Enhance Affect Down-regulation

NCT06626789 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-02-03

No results posted yet for this study

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.

Conditions

  • Borderline Personality Disorder

Interventions

BIOLOGICAL

Amygdala neurofeedback

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.

BEHAVIORAL

Sham neurofeedback

Recorded neurofeedback from a different participant + negative emotional picture viewing. Instruction to regulate feedback via down-regulation of one's emotional response.

Sponsors & Collaborators

  • University Medical Center Freiburg

    collaborator OTHER

  • University of Giessen

    collaborator OTHER

  • University Hospital Tuebingen

    collaborator OTHER

  • Central Institute of Mental Health, Mannheim

    lead OTHER

Principal Investigators

  • Christian Paret-Voigt, Dr. · ZI Mannheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-23
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06626789 on ClinicalTrials.gov