Borderline Personality DisorderNCT03636139
Cognitive Control of Negative Stimuli in BPD
A study testing transcranial DC stimulation : anodal in people with Borderline Personality Disorder, run by Freie Universität Berlin.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- transcranial DC stimulation : anodal
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of borderline personality disorder
- No current or previous diagnosis of a mental disorder
Who cannot join
- 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)
- More than 2 criteria of borderline personality disorder are met
Show all 9Show fewer
- 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)
About this study
Official title: 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- transcranial DC stimulation : anodal, transcranial DC stimulation : sham
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial DC stimulation : anodalDevice
anodal stimulation of the right dlPFC (i.e. F4) for 20 minutes
transcranial DC stimulation : shamDevice
sham stimulation of the right dlPFC (i.e. F4) for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Anodal stimulation | Experimental | transcranial DC stimulation : anodal Receives: Device: transcranial DC stimulation : anodal |
| Sham stimulation | Sham comparator | transcranial DC stimulation : sham Receives: Device: transcranial DC stimulation : sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Response latencies were exclusively measured during the assigned interventions, which lasted approx. 20 minutes. No further time points were assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study startJan 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Freie Universität Berlin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Schulze, Freie Universität Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636139
- Sponsor's protocol ID
- tDCS_BPD
- Status last verified
- Feb 2024
- First submitted
- 10 Aug 2018
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation on the Cognitive Control of Negative Stimuli in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT03636139
- Acronym / sponsor ID
- tDCS_BPD
- Conditions
- Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Freie Universität BerlinUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal stimulation | Experimental | Device: transcranial DC stimulation : anodaltranscranial DC stimulation : anodal |
| Sham stimulation | Sham comparator | Device: transcranial DC stimulation : shamtranscranial DC stimulation : sham |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of borderline personality disorder
- No current or previous diagnosis of a mental disorder
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial DC stimulation : anodalanodal stimulation of the right dlPFC (i.e. F4) for 20 minutes | Device | Anodal stimulation |
| transcranial DC stimulation : shamsham stimulation of the right dlPFC (i.e. F4) for 20 minutes | Device | Sham stimulation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial DC stimulation : anodal in people with Borderline Personality Disorder, run by Freie Universität Berlin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response latencies (time frame: Response latencies were exclusively measured during the assigned interventions, which lasted approx. 20 minutes. No further time points were assessed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.