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Cognitive Control of Negative Stimuli in BPD

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcranial DC stimulation : anodal
transcranial DC stimulation : sham
Sponsored by
Freie Universität Berlin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Borderline Personality Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Borderline Personality Disorder:

  • Diagnosis of borderline personality disorder

Exclusion Criteria Borderline Personality Disorder:

  • Diagnosis of current or previous bipolar disorder
  • Diagnosis of current substance dependency
  • Diagnosis of current major depression
  • Diagnosis of current or previous neurological disorders (e.g., epilepsy)
  • Tattoos or scarred skin on the left shoulder or scalp (i.e. F4)

Inclusion Criteria Control Participants:

  • No current or previous diagnosis of a mental disorder

Exclusion Criteria Control Participants:

  • More than 2 criteria of borderline personality disorder are met
  • Diagnosis of current or previous neurological disorders (e.g., epilepsy)
  • Intake of psychotropic medication
  • Tattoos or scarred skin on the left shoulder or scalp (i.e. F4)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Anodal stimulation

    Sham stimulation

    Arm Description

    transcranial DC stimulation : anodal

    transcranial DC stimulation : sham

    Outcomes

    Primary Outcome Measures

    Response latencies
    Response latencies were measured in the context of a delayed working memory task. In this paradigm, each trial started with a fixation cross (1000 ms), followed by the presentation of six target letters (1500 ms), which participants were asked to memorize. After a variable distracter period (i.e., interference duration of 1000, 2000, or 4000 ms), participants were presented a recognition display (until a response was made) and had to decide whether the presented letter was part of the initial set of letters. In half of the trials, the recognition display contained a previously presented target. The distracter period of the experimental paradigm was manipulated with regard to the factors valence (grey background screen, or neutral, or negative stimuli) and interference duration (1000, 2000, or 4000 ms). Neutral and negative affective stimuli were selected from the International Affective Picture System.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 10, 2018
    Last Updated
    August 16, 2018
    Sponsor
    Freie Universität Berlin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03636139
    Brief Title
    Cognitive Control of Negative Stimuli in BPD
    Official Title
    Effects of Transcranial Direct Current Stimulation on the Cognitive Control of Negative Stimuli in Borderline Personality Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    June 2017 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Freie Universität Berlin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Borderline personality disorder (BPD) is characterized by impairments in the cognitive control of negative information. These impairments in cognitive control are presumably due to blunted activity of the dorsolateral prefrontal cortex (dlPFC) along with enhanced activations of the limbic system. However, the impact of an excitatory stimulation of the dlPFC still needs to be elucidated. In the present study, we therefore assigned 50 patients with BPD and 50 healthy controls to receive either anodal or sham stimulation of the right dlPFC in a double-blind, randomized, between-subjects design.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Borderline Personality Disorder

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anodal stimulation
    Arm Type
    Experimental
    Arm Description
    transcranial DC stimulation : anodal
    Arm Title
    Sham stimulation
    Arm Type
    Sham Comparator
    Arm Description
    transcranial DC stimulation : sham
    Intervention Type
    Device
    Intervention Name(s)
    transcranial DC stimulation : anodal
    Intervention Description
    anodal stimulation of the right dlPFC (i.e. F4) for 20 minutes
    Intervention Type
    Device
    Intervention Name(s)
    transcranial DC stimulation : sham
    Intervention Description
    sham stimulation of the right dlPFC (i.e. F4) for 20 minutes
    Primary Outcome Measure Information:
    Title
    Response latencies
    Description
    Response latencies were measured in the context of a delayed working memory task. In this paradigm, each trial started with a fixation cross (1000 ms), followed by the presentation of six target letters (1500 ms), which participants were asked to memorize. After a variable distracter period (i.e., interference duration of 1000, 2000, or 4000 ms), participants were presented a recognition display (until a response was made) and had to decide whether the presented letter was part of the initial set of letters. In half of the trials, the recognition display contained a previously presented target. The distracter period of the experimental paradigm was manipulated with regard to the factors valence (grey background screen, or neutral, or negative stimuli) and interference duration (1000, 2000, or 4000 ms). Neutral and negative affective stimuli were selected from the International Affective Picture System.
    Time Frame
    Response latencies were exclusively measured during the assigned interventions, which lasted approx. 20 minutes. No further time points were assessed.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria Borderline Personality Disorder: Diagnosis of borderline personality disorder Exclusion Criteria Borderline Personality Disorder: Diagnosis of current or previous bipolar disorder Diagnosis of current substance dependency Diagnosis of current major depression Diagnosis of current or previous neurological disorders (e.g., epilepsy) Tattoos or scarred skin on the left shoulder or scalp (i.e. F4) Inclusion Criteria Control Participants: No current or previous diagnosis of a mental disorder Exclusion Criteria Control Participants: More than 2 criteria of borderline personality disorder are met Diagnosis of current or previous neurological disorders (e.g., epilepsy) Intake of psychotropic medication Tattoos or scarred skin on the left shoulder or scalp (i.e. F4)

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Cognitive Control of Negative Stimuli in BPD

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