NCT02866110

Brief Summary

Emotion-related brain activation is made visible for patients via neurofeedback with the aim to improve discriminability of emotional arousal and emotion regulation. With functional magnetic resonance imaging (fMRI), information of current brain activation is imaged and fed back to the patient via a visual display. Patients with borderline personality disorder (BPD) usually hyper-activate brain regions associated with emotion. In this study, BPD patients will be provided with neurofeedback from the amygdala, which is crucial for the processing of emotions. The aim of the study is to observe, whether amygdala-neurofeedback would help BPD patients to improve emotion regulation. Compared to a control condition, improved brain self-regulation and emotion regulation is expected with three neurofeedback training sessions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

1.7 years

First QC Date

July 28, 2016

Last Update Submit

November 19, 2018

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (5)

  • Change in self-assessment of emotion regulation capability after training

    Questionnaire: Difficulties in Emotion Regulation Scale (DERS)

    T0: max 7 days before first training session (depends on patient's availability), T1: max 7 days after third training session, T2 (Follow up): 6 weeks after T1

  • Change in emotion regulation after training, assessed by fear-potentiated startle response

    Fear-potentiated startle with instructed emotion regulation vs. natural responding to emotional pictures

    T0: max 7 days before first training session (depends on patient's availability), T1: max 7 days after third training session, T2 (Follow up): 6 weeks after T1

  • Change in heart rate variability after training

    Peripheral physiologic measure: resting heart rate variability (relation of high vs. low frequencies in spectrum)

    T0: max 7 days before first training session (depends on patient's availability), T1: max 7 days after third training session, T2 (Follow up): 6 weeks after T1

  • Change in amygdala response to masked faces after training

    Central nervous system measures: amygdala BOLD response to masked affective facial expressions

    T0: max 7 days before first training session (depends on patient's availability), T1: max 7 days after third training session, T2 (Follow up): 6 weeks after T1

  • Change in amygdala response in emotional working memory task after training

    Central nervous system measures: amygdala BOLD response in Sternberg-Working Memory test with emotional vs. neutral distractor images

    T0: max 7 days before first training session (depends on patient's availability), T1: max 7 days after third training session, T2 (Follow up): 6 weeks after T1

Secondary Outcomes (1)

  • Change in BPD symptom severity after training

    T0: max 7 days before first training session (depends on patient's availability), T1: max 7 days after third training session, T2 (Follow up): 6 weeks after T1

Study Arms (1)

Treatment group

EXPERIMENTAL

25 patients with BPD. In a diagnostic session, diagnostics of psychiatric disorders are conducted. For BPD diagnosis, the International Personality Disorder Examination (IPDE) is used and symptom severity is assessed with the Borderline Symptom List. The Treatment group will receive fMRI amygdala neurofeedback training (3 sessions within 2 weeks). Patients in regular psychotherapeutic treatment (treatment-as-usual) will not be excluded.

Behavioral: NeurofeedbackDevice: MRI

Interventions

NeurofeedbackBEHAVIORAL

The Blood Oxygenation Level Dependent (BOLD) signal from the amygdala, recorded with functional magnetic resonance imaging, is utilized as a feedback signal to patients.

Also known as: real-time fMRI Neurofeedback
Treatment group
MRIDEVICE

Echo-planar Imaging of brain BOLD signal

Also known as: Magnetic Resonance Imaging
Treatment group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Current BPD (≥ 5 DSM-V criteria), female, informed consent for study participation

You may not qualify if:

  • Psychotropic medication 2 weeks before start (SSRIs excluded)
  • Lifetime diagnosis of schizophrenia or bipolar I
  • Substance dependence in the preceding year
  • Current substance use
  • Pregnancy
  • Epilepsy
  • Antecedent cranial or brain injuries
  • Organic brain diseases
  • Severe medical or neurological condition
  • BMI\<16.5
  • Metallic non-removable items in or on the body which are not MR compatible,
  • Permanent make-up
  • Claustrophobia, left-handedness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Institute of Mental Health

Mannheim, D-68159, Germany

Location

Related Publications (3)

  • 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: 26833918BACKGROUND

  • Paret C, Ruf M, Gerchen MF, Kluetsch R, Demirakca T, Jungkunz M, Bertsch K, Schmahl C, Ende G. fMRI neurofeedback of amygdala response to aversive stimuli enhances prefrontal-limbic brain connectivity. Neuroimage. 2016 Jan 15;125:182-188. doi: 10.1016/j.neuroimage.2015.10.027. Epub 2015 Oct 16.

    PMID: 26481674BACKGROUND

  • 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: 25278851BACKGROUND

Related Links

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

NeurofeedbackMagnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Gabriele Ende, Professor

    Central Institute of Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Christian Schmahl

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 15, 2016

Study Start

October 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

Pseudonymized data will be shared with projects from the BrainTrain-network, http://www.braintrainproject.eu

Locations

DE(1)