Clinical trial NCT03498937: Effects of tDCS on Impulsiveness Among People Suffering From Borderline Personality Disorder
Official title: Effet de la tDCS Sur l'impulsivité Chez Les Personnes Souffrant d'un Trouble Borderline : TIMBER
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Borderline Personality Disorder
Impulsive Behavior
Keywords: Borderline Personality Disorder
Impulsive behavior
Suicidal behavior
Cognitive control
tDCS
Noninvasive brain stimulation
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the impact of transcranial direct current stimulation (tDCS) on impulsiveness of adults suffering from Borderline Personality Disorder. Short- and long-term effects are assessed by electroencephalography (EEG) records, experimental tasks and self-rated scales.

Detailed description: Impulsivity, considered as the tendency to express spontaneous, excessive and/or unplanned behavior, is recognized as a major factor involved in suicidal behavior and self-harm behaviors. It consists in one of the diagnostic criteria of Borderline Personality Disorder, allowing as well assessment of its clinical severity. There is so far no specific treatment concerning impulsivity. From a neurobiological perspective, the prefrontal cortex is considered as a critical region in the cognitive control of behaviors. Previous studies have associated an hypoactivation of the dorsolateral prefrontal cortex (dlPFC) and the dorsal part of the anterior cingulate cortex to Borderline Personality Disorder.

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.

Eligibility criteria: Inclusion Criteria:

* Man or woman older than 18 years old
* 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:

* Younger than 18 years old
* 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"

Primary outcomes:
measure: EPs during BART
timeFrame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Secondary outcomes:
measure: BIS-10 scores
timeFrame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
measure: HDRS scores
timeFrame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
measure: UPPS-P scores
timeFrame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
measure: MADRS scores
timeFrame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
measure: C-SSRS scores
timeFrame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
measure: Go/No-Go task
timeFrame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
measure: Stroop task
timeFrame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besancon
state: Franche-Comte
city: Nancy
country: France
facility: Pôle Hospitalo-Universitaire de Psychiatrie du Grand Nancy
city: Rouffach
country: France
facility: Centre Hospitalier Spécialisé de Rouffach
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Djamila BENNABI, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.