Effects of tDCS on Impulsiveness Among People Suffering From Borderline Personality Disorder
NCT ID: NCT03498937
Last Updated: 2019-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2019-05-31
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cognitive Control of Negative Stimuli in BPD
NCT03636139
Impulsivity With Borderline Personality Disorder/tMS
NCT05942651
Transcranial Magnetic Stimulation for Borderline Personality Disorder
NCT01076933
The Effect of Non Invasive Brain Stimulation on Impulsivity in Borderline Personality Disorder
NCT05453032
Transcranial Magnetic Stimulation on Dorsomedial Prefrontal Cortex in Borderline Personality Disorder
NCT03832777
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Transcranial direct current stimulation (tDCS) is a technique of noninvasive brain stimulation which delivers a subthreshold electrical current to the scalp, manipulating the resting membrane potential. It has shown cognitive function improvement, both in healthy individuals and psychiatric populations. Modulation of the dlPFC could therefore represent a mean of reducing impulsivity in those patients.
With a prospective, sham-controlled, crossover, double-blind design, this study aims to evaluate the impact of bilateral tDCS over the dlPFC on the impulsive dimension of adults suffering from Borderline Personality Disorder. Subjects will be submitted to 10 tDCS stimulation sessions (active or sham) for five consecutive days (2 sessions of 30 minutes/day). Current intensity will be of 2 mA, through 25 cm² surface electrodes, placed over the dlPFC (anode position over F4 and cathode over F3, according to the EEG 10-20 international system). Subjects who undergo active stimulation sessions will be then submitted to sham sessions and vice-versa. Baseline measures will be compared to those obtained immediately after the end of sessions (5 days: short-term effects), and to 12 and 30 days later (long-term effects). Active and sham stimulation sessions outcomes will as well be compared.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Subjects suffering from Borderline Personality Disorder randomly assigned to start the trial by 10 active tDCS sessions, followed by 10 sham tDCS sessions
Active tDCS
10 active tDCS sessions (2 sessions/day for 5 days, 30 min each, 2 mA) applied to the dlPFC
Sham tDCS
10 sham tDCS sessions (2 sessions/day for 5 days, 30 min each, 0 mA) applied to the dlPFC
Group 2
Subjects suffering from Borderline Personality Disorder randomly assigned to start the trial by 10 sham tDCS sessions, followed by 10 active tDCS sessions
Active tDCS
10 active tDCS sessions (2 sessions/day for 5 days, 30 min each, 2 mA) applied to the dlPFC
Sham tDCS
10 sham tDCS sessions (2 sessions/day for 5 days, 30 min each, 0 mA) applied to the dlPFC
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Active tDCS
10 active tDCS sessions (2 sessions/day for 5 days, 30 min each, 2 mA) applied to the dlPFC
Sham tDCS
10 sham tDCS sessions (2 sessions/day for 5 days, 30 min each, 0 mA) applied to the dlPFC
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Right-handed
* Signed Informed Consent form
* Subject affiliated to or beneficiary from a French social security regime
* Inpatient or outpatient at the Adult Psychiatry Service
* Diagnosis of Borderline Personality Disorder according to the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and confirmation by the Structured Clinical Interview for DSM Disorders (SCID-II)
* Absence of addictive comorbidities (except: tobacco, tea, coffee)
* Absence of severe progressive neurologic and/or somatic pathologies (specially tumors, degenerative diseases)
Exclusion Criteria
* Left-handed
* Subject under measure of protection or guardianship of justice
* Presence of psychiatric comorbidities (chronic psychosis, Bipolar Disorder)
* Subject beneficiary from a legal protection regime
* Subject unlikely to cooperate or low cooperation stated by investigator
* Subject not covered by social security
* Pregnant woman
* Subject being in the exclusion period of another study or provided for by the "National Volunteer File"
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Djamila BENNABI, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Besancon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Besancon
Besançon, Franche-Comte, France
Pôle Hospitalo-Universitaire de Psychiatrie du Grand Nancy
Nancy, , France
Centre Hospitalier Spécialisé de Rouffach
Rouffach, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
Teti Mayer J, Nicolier M, Gabriel D, Masse C, Giustiniani J, Compagne C, Vandel P, Pazart L, Haffen E, Bennabi D. Efficacy of transcranial direct current stimulation in reducing impulsivity in borderline personality disorder (TIMBER): study protocol of a randomized controlled clinical trial. Trials. 2019 Jun 10;20(1):347. doi: 10.1186/s13063-019-3427-z.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P/2017/319
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.