Brain Signal Training to Enhance Affect Down-regulation

NCT06626789 | Recruiting Phase 1 DMC

• 1 other identifier: BrainSTEADy
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Neurofeedback; fMRI; Neuroimaging; Amygdala; Affect instability; Emotion

Outcome Measures

Primary Outcomes (1)

• Affect Intensity, change from T0 to T1

  Mean score of negative affect scale measured via experience sampling using ecological momentary assessment (EMA). Scale can take values from 1 to 7, high values mean higher affect intensity. EMA is conducted across 4 consecutive days, including a full weekend, when patients carry a smartphone that runs the EMA app. The app sends an auditory signal every hour, starting at 9 AM until 9 PM, to remind the patient to fill out the items.

  Completion of T0 EMA sampling within 12 days before first NF session. Start of T1 EMA sampling within 1 week after last NF session.

Secondary Outcomes (5)

• Affect Intensity, change from T0 to T2

  Completion of T0 EMA sampling within 12 days before first NF session. Start of T2 EMA sampling within 14-16 weeks after last NF session.

• Borderline Symptom Severity, change from T0 to T1 and T0 to T2

  T0 assessed before first NF session (within 1-3 weeks). T1 assessed after last NF session (within 2-4 weeks). T2 assessed within 14-16 weeks after last NF session.

• Amygdala response, change from T0 to T1.

  Time Frame: T0 assessed at Baseline. T1 assessed at Post-Assessment immediately after treatment.

• Amygdala self-regulation, change from T0 to T1.

  Time Frame: T0 assessed at Baseline. T1 assessed at Post-Assessment immediately after treatment.

• Improvement in quality-adjusted life years (QALY), change from T0 to T3

  T0 assessed before first nf session (within 1-3 weeks). T3 assessed 6 months after last NF session.

Study Arms (2)

Intervention group

EXPERIMENTAL

Real-time functional Magnetic Resonance Imaging (fMRI) neurofeedback from the Blood Oxygenation Level Dependent (BOLD) signal of the amygdala

Biological: Amygdala neurofeedback

Control group

EXPERIMENTAL

Feedback that is less correlated with amygdala BOLD signal

Behavioral: Sham neurofeedback

Interventions

Amygdala neurofeedback BIOLOGICAL

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.

Intervention group

Sham neurofeedback BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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, 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

Sponsors & Collaborators

• University Medical Center Freiburg: collaborator
• Central Institute of Mental Health, Mannheim: lead
• University of Giessen: collaborator
• University Hospital Tuebingen: collaborator

Study Sites (6)

University clinic Freiburg

Freiburg im Breisgau, 79104, Germany

RECRUITING

University clinic Giessen

Giessen, 35392, Germany

RECRUITING

University Clinic Halle (Saale)

Halle, Germany

NOT YET RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

Central Institute of Mental Health

Mannheim, 68159, Germany

RECRUITING

University Clinic Tuebingen

Tübingen, 72076, Germany

RECRUITING

Related Publications (4)

• Zaehringer J, Ende G, Santangelo P, Kleindienst N, Ruf M, Bertsch K, Bohus M, Schmahl C, Paret C. Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder. Neuroimage Clin. 2019;24:102032. doi: 10.1016/j.nicl.2019.102032. Epub 2019 Oct 16.

  PMID: 31795041 BACKGROUND

• Paret C, Kluetsch R, Zaehringer J, Ruf M, Demirakca T, Bohus M, Ende G, Schmahl C. Alterations of amygdala-prefrontal connectivity with real-time fMRI neurofeedback in BPD patients. Soc Cogn Affect Neurosci. 2016 Jun;11(6):952-60. doi: 10.1093/scan/nsw016. Epub 2016 Feb 1.

  PMID: 26833918 BACKGROUND

• Paret C, Kluetsch R, Ruf M, Demirakca T, Hoesterey S, Ende G, Schmahl C. Down-regulation of amygdala activation with real-time fMRI neurofeedback in a healthy female sample. Front Behav Neurosci. 2014 Sep 18;8:299. doi: 10.3389/fnbeh.2014.00299. eCollection 2014.

  PMID: 25278851 BACKGROUND

• Paret C, Jindrova M, Kleindienst N, Eck J, Breman H, Luhrs M, Barth B, Ethofer T, Fallgatter AJ, Goebel R, Hoell A, Lockhofen D, Reinhold AS, Maier S, Matthies S, Mulert C, Schonholz C, van Elst LT, Schmahl C. A randomised controlled trial of amygdala fMRI-neurofeedback versus sham-feedback in borderline-personality disorder - systematic literature review and introduction to the BrainSTEADy trial. BMC Psychiatry. 2025 Jul 8;25(1):687. doi: 10.1186/s12888-025-07000-1.

  PMID: 40629288 DERIVED

Related Links

• Trial recruitment website

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Christian Paret-Voigt, Dr.

  ZI Mannheim

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Paret-Voigt, Dr.

CONTACT

+4962117034462; christian.paret@zi-mannheim.de

Miroslava Hofmanová

CONTACT

+4962117034463; miroslava.hofmanova@zi-mannheim.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinical Research Organization (sub-contractor) responsible for interim analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: October 4, 2024
• Study Start: April 23, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The data will be made available within 1 year after completion of data collection. Data will be available for at least 10 years.
• Access Criteria: IPD can be shared with researchers who are located in countries with a data protection level that is equivalent with the EU-GDPR. Researcher have to request access at the repository website.

Locations

DE (6)