- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03636139
Cognitive Control of Negative Stimuli in BPD
February 21, 2024 updated by: Lars Schulze, Freie Universität Berlin
Effects of Transcranial Direct Current Stimulation on the Cognitive Control of Negative Stimuli in Borderline Personality Disorder
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anodal stimulation
transcranial DC stimulation : anodal
|
anodal stimulation of the right dlPFC (i.e.
F4) for 20 minutes
|
Sham Comparator: Sham stimulation
transcranial DC stimulation : sham
|
sham stimulation of the right dlPFC (i.e.
F4) for 20 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response latencies
Time Frame: Response latencies were exclusively measured during the assigned interventions, which lasted approx. 20 minutes. No further time points were assessed.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
August 10, 2018
First Submitted That Met QC Criteria
August 15, 2018
First Posted (Actual)
August 17, 2018
Study Record Updates
Last Update Posted (Estimated)
February 22, 2024
Last Update Submitted That Met QC Criteria
February 21, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- tDCS_BPD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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