Training of Neural Responding in BPD

NCT ID: NCT02866110

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-07-31

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.

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.

Conditions

Borderline Personality Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Neurofeedback

Intervention Type: 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.

MRI

Intervention Type: DEVICE

Echo-planar Imaging of brain BOLD signal

Interventions

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.

Intervention Type: BEHAVIORAL

MRI

Echo-planar Imaging of brain BOLD signal

Intervention Type: DEVICE

Other Intervention Names

real-time fMRI Neurofeedback; Magnetic Resonance Imaging

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Christian Schmahl

Prof. Dr. med. Christian Schmahl

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabriele Ende, Professor

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health

Locations

Central Institute of Mental Health

Mannheim, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 26833918 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26481674 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25278851 (View on PubMed)

Related Links

https://www.zi-mannheim.de/

Institute Website

Other Identifiers

DRKS00009363

Identifier Type: REGISTRY

Identifier Source: secondary_id

KFO_IP5

Identifier Type: -

Identifier Source: org_study_id