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Completed

NCT Number: NCT02866110

Training of Neural Responding in BPD

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Central Institute of Mental Health

Mannheim, D-68159, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurofeedback

Behavioral

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

MRI

Device

Echo-planar Imaging of brain BOLD signal

Other names: Magnetic Resonance Imaging

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Central Institute of Mental Health, Mannheim

Other

Registry information

Official study title

Training of Neural Responding With fMRI Neurofeedback in Borderline Personality Disorder

Acronym: IP5n

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2016
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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