Brain Signal Training to Enhance Affect Down-regulation
NCT ID: NCT06626789
Last Updated: 2026-02-03
Study Results
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Basic Information
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RECRUITING
PHASE1/PHASE2
164 participants
INTERVENTIONAL
2025-04-23
2028-06-30
Brief Summary
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Detailed Description
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Functional magnetic resonance imaging (fMRI) allows the recording of activation in subcortical brain regions, such as the amygdala, in real time. Live feedback from brain activation (e.g. via a thermometer with the temperature reflecting the degree of activation) allows one to learn the voluntary control of the brain. Dubbed "neurofeedback" (NF), the method can result in long-lasting changes in neural activation patterns. NF allows precise targeting of dysfunctional neuro-circuitries that relate to clinical symptoms.
The project proposed here investigates the clinical effectivity of fMRI-based amygdala-NF training in BPD. In total, 164 patients will participate in four training sessions provided by four study centers: Tuebingen, Freiburg, Giessen, and Mannheim. The training aims to reduce affective instability in everyday life, which is assessed primarily by ambulatory assessment before and after treatment. During NF sessions, patients receive feedback from the BOLD (Blood Oxygenation Level Dependent) signal recorded in the amygdala while they view pictures with negative emotional content. The amygdala responds to these pictures with an activation increase. The patient observes the amygdala responding, illustrated via increased temperature in a thermometer beside the picture. The task is to decrease temperature. The procedure should teach patients to master overreaction at an early stage of neural emotion processing.
To assess the effectivity of amygdala-NF, a control group receives non-veridical feedback from a different patient. The investigators expect a significant reduction in affective instability with amygdala-NF. In addition, the investigators expect a greater reduction in affective instability in the amygdala-NF group versus the control group.
The trial will go through two stages of recruitment. Stage 1 is reached after recruitment of 82 participants. An interim analysis will be conducted. Depending on the results of the interim analysis, the trial will enter stage 2, ie. recruitment of the full number of planned participants.
Results from this study enable assessment of clinical efficacy of amygdala-NF. In the future, NF could serve as a precise tool for person-centered treatment of affective instability symptoms in mental disorders with severe emotion regulation problems such as BPD.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intervention group
Real-time functional Magnetic Resonance Imaging (fMRI) neurofeedback from the Blood Oxygenation Level Dependent (BOLD) signal of the amygdala
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.
Control group
Feedback that is less correlated with amygdala BOLD signal
Sham neurofeedback
Recorded neurofeedback from a different participant + negative emotional picture viewing. Instruction to regulate feedback via down-regulation of one's emotional response.
Interventions
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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.
Sham neurofeedback
Recorded neurofeedback from a different participant + negative emotional picture viewing. Instruction to regulate feedback via down-regulation of one's emotional response.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of Borderline Personality Disorder
3. Insufficient response to ≥2 therapies.
4. 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
5. Ability of subject to understand character and individual consequences of clinical investigation
6. Written informed consent (must be available before enrollment in the clinical investigation)
7. For women of childbearing potential (WOCBP) adequate contraception.
Exclusion Criteria
2. Current alcohol or substance dependence
3. Meeting the diagnostic criteria for a psychotic disorder or schizophrenia (life-time), as determined by clinical interview at initial screening
4. 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)
5. Significant visual impairment that might interfere with the performance of the behavioural tasks or fMRI tasks
6. Change of treatment (psychopharmacologic, psychological) 2 weeks prior to or during the study participation
7. Treatment with any neurofeedback three months prior to or during the study participation.
8. Unable or unwilling to comply with study procedures, including study prohibitions and restrictions
9. History of claustrophobia or inability to tolerate scanner environment
10. Fulfilling any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants)
11. Clinically relevant structural brain abnormality as determined by prior MRI scan
12. Planned medical treatment within the study period that might interfere with the study procedures
13. Participants deemed to be at significant risk of serious violence or suicide
14. BMI of 16.5 or lower
15. Participation in other clinical trials or observation period of competing trials, respectively
16. Previous participation in this trial
17. Pregnancy and lactation
18. Held in an institution by legal or official order
19. Legally incapacitated.
18 Years
65 Years
ALL
No
Sponsors
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University Medical Center Freiburg
OTHER
University of Giessen
OTHER
University Hospital Tuebingen
OTHER
Central Institute of Mental Health, Mannheim
OTHER
Responsible Party
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Principal Investigators
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Christian Paret-Voigt, Dr.
Role: PRINCIPAL_INVESTIGATOR
ZI Mannheim
Locations
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University clinic Freiburg
Freiburg im Breisgau, , Germany
University clinic Giessen
Giessen, , Germany
University Clinic Halle (Saale)
Halle, , Germany
University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
Central Institute of Mental Health
Mannheim, , Germany
University Clinic Tuebingen
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Trial recruitment website
Other Identifiers
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BrainSTEADy
Identifier Type: -
Identifier Source: org_study_id
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