Training of Neural Responding in BPD (IP5n)

November 19, 2018 updated by: Christian Schmahl, Central Institute of Mental Health, Mannheim

Training of Neural Responding With fMRI Neurofeedback in Borderline Personality Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with BPD show increased emotional reactivity, slow return to baseline, and severe emotion dysregulation symptoms. On the neural level, BPD patients hyper-activate the amygdala and hypo-activate the prefrontal cortex in response to emotional stimuli. The prefrontal cortex and the amygdala are crucial nodes of the brain's emotion regulation network and thus it is assumed, that dysregulation within this network is key to BPD symptoms. Psychotherapy treatments specialized for BPD teach patients to monitor emotional arousal and to develop emotion regulation skills. However in the long run and despite of important therapeutic advances, the majority of BPD patients keep reporting significant impairments in functioning after psychotherapy.

To explore new types of therapy in BPD, the investigators have applied real-time fMRI neurofeedback, where patients are provided with their brain activation via a visual display. In previous work they found that BPD patients and healthy participants can down-regulate amygdala activation with real-time fMRI neurofeedback, and increase connectivity between the amygdala and the prefrontal cortex. Yet, we do not yet fully understand the potential effects of amygdala neurofeedback on emotion.

BPD patients (n=25) participate in a three-session fMRI neurofeedback training with 2-7 days between sessions (within 2 weeks). The effect of the training will be measured before and after training. Primarily, the investigators expect an improvement in emotion regulation, secondarily, reductions in BPD symptoms are expected.

Hypotheses:

With fMRI neurofeedback, BPD patients improve significantly in self-report and psychophysiological measures of emotion regulation with fMRI neurofeedback training. BPD patients show significantly reduced symptom severity in self-report measures with neurofeedback training.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany, D-68159
        • Central Institute of Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
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: Neurofeedback
The Blood Oxygenation Level Dependent (BOLD) signal from the amygdala, recorded with functional magnetic resonance imaging, is utilized as a feedback signal to patients.
Other Names:
  • real-time fMRI Neurofeedback
Device: MRI
Echo-planar Imaging of brain BOLD signal
Other Names:
  • Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-assessment of emotion regulation capability after training
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BPD symptom severity after training
Time Frame: 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
ZAN-BPD structured interview (acquisition in T0 and T2), BSL-23 self-report questionnaire (acquisition in T0, T1, T2; time lag matched to treatment group).
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Institute of Mental Health, Mannheim

Investigators

  • Principal Investigator: Gabriele Ende, Professor, Central Institute of Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimate)

August 15, 2016

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFO_IP5
  • DRKS00009363 (Registry Identifier: German Clinical Trials Register, DRKS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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