NCT03636139

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

1.4 years

First QC Date

August 10, 2018

Last Update Submit

February 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Response latencies were exclusively measured during the assigned interventions, which lasted approx. 20 minutes. No further time points were assessed.

Study Arms (2)

Anodal stimulation

EXPERIMENTAL

transcranial DC stimulation : anodal

Device: transcranial DC stimulation : anodal

Sham stimulation

SHAM COMPARATOR

transcranial DC stimulation : sham

Device: transcranial DC stimulation : sham

Interventions

anodal stimulation of the right dlPFC (i.e. F4) for 20 minutes

Anodal stimulation

sham stimulation of the right dlPFC (i.e. F4) for 20 minutes

Sham stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of borderline personality disorder

You may not qualify if:

  • 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)
  • No current or previous diagnosis of a mental disorder
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 17, 2018

Study Start

January 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

February 22, 2024

Record last verified: 2024-02