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Training of Neural Responding in BPD

Training of Neural Responding With fMRI Neurofeedback in Borderline Personality Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02866110
Acronym
IP5n
Enrollment
25
Registered
2016-08-15
Start date
2016-10-31
Completion date
2018-07-31
Last updated
2018-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder

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.

Interventions

BEHAVIORALNeurofeedback

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

DEVICEMRI

Echo-planar Imaging of brain BOLD signal

Sponsors

Central Institute of Mental Health, Mannheim
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in self-assessment of emotion regulation capability after trainingT0: 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 T1Questionnaire: Difficulties in Emotion Regulation Scale (DERS)
Change in emotion regulation after training, assessed by fear-potentiated startle responseT0: 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 T1Fear-potentiated startle with instructed emotion regulation vs. natural responding to emotional pictures
Change in heart rate variability after trainingT0: 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 T1Peripheral physiologic measure: resting heart rate variability (relation of high vs. low frequencies in spectrum)
Change in amygdala response to masked faces after trainingT0: 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 T1Central nervous system measures: amygdala BOLD response to masked affective facial expressions
Change in amygdala response in emotional working memory task after trainingT0: 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 T1Central nervous system measures: amygdala BOLD response in Sternberg-Working Memory test with emotional vs. neutral distractor images

Secondary

MeasureTime frameDescription
Change in BPD symptom severity after trainingT0: 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 T1ZAN-BPD structured interview (acquisition in T0 and T2), BSL-23 self-report questionnaire (acquisition in T0, T1, T2; time lag matched to treatment group).

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026