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Training of Neural Responding in BPD (IP5n)

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ClinicalTrials.gov Identifier: NCT02866110
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Christian Schmahl, Central Institute of Mental Health, Mannheim

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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Behavioral: Neurofeedback Device: MRI Not Applicable

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  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Training of Neural Responding With fMRI Neurofeedback in Borderline Personality Disorder
Study Start Date : October 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


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 Name: real-time fMRI Neurofeedback

Device: MRI
Echo-planar Imaging of brain BOLD signal
Other Name: Magnetic Resonance Imaging




Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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)

  4. 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

  5. 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


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866110


Locations
Germany
Central Institute of Mental Health
Mannheim, Germany, D-68159
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
Investigators
Principal Investigator: Gabriele Ende, Professor Central Institute of Mental Health

Additional Information:
Publications:
Responsible Party: Christian Schmahl, Prof. Dr. med. Christian Schmahl, Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT02866110     History of Changes
Other Study ID Numbers: KFO_IP5
DRKS00009363 ( Registry Identifier: German Clinical Trials Register, DRKS )
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pseudonymized data will be shared with projects from the BrainTrain-network, http://www.braintrainproject.eu

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders