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Effects of tDCS on Impulsiveness Among People Suffering From Borderline Personality Disorder (TIMBER)

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ClinicalTrials.gov Identifier: NCT03498937
Recruitment Status : Not yet recruiting
First Posted : April 17, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Impulsive Behavior Device: Active tDCS Device: Sham tDCS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effet de la tDCS Sur l'impulsivité Chez Les Personnes Souffrant d'un Trouble Borderline : TIMBER
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Device: Active tDCS
10 active tDCS sessions (2 sessions/day for 5 days, 30 min each, 2 mA) applied to the dlPFC
Other Name: Starstim® (Neuroelectrics, Spain)

Device: Sham tDCS
10 sham tDCS sessions (2 sessions/day for 5 days, 30 min each, 0 mA) applied to the dlPFC
Other Name: Starstim® (Neuroelectrics, Spain)

Experimental: 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
Device: Active tDCS
10 active tDCS sessions (2 sessions/day for 5 days, 30 min each, 2 mA) applied to the dlPFC
Other Name: Starstim® (Neuroelectrics, Spain)

Device: Sham tDCS
10 sham tDCS sessions (2 sessions/day for 5 days, 30 min each, 0 mA) applied to the dlPFC
Other Name: Starstim® (Neuroelectrics, Spain)




Primary Outcome Measures :
  1. EPs during BART [ Time Frame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS ]
    Amplitude variation of evoked potentials (EPs) detected by electroencephalography (EEG) during the Balloon Analogue Risk Task (BART), assessing risk-taking behavior. Variation will be obtained by comparing records before beginning of stimulation sessions with 5, 12 and 30 days after active and/or sham tDCS.


Secondary Outcome Measures :
  1. BIS-10 scores [ Time Frame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS ]
    Compared scores from the French version of the Barratt Impulsiveness Scale (BIS-10). The French version of the BIS-10 is a self-rated 34 item questionnaire, composed by three subscales: motor-impulsivity, cognitive-impulsivity and non-planning-impulsivity. Each item is scored on a 0 to 4 points scale. Higher scores indicate higher levels of impulsivity.

  2. HDRS scores [ Time Frame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS ]
    Compared scores from the Hamilton Depression Rating Scale (HDRS). The HDRS is a clinician-rated 17 item scale which allows depression severity assessment and follow-up. Each item is scored on a 3 or 5 point scale. Scores are represented as follows: 0-7 Normal, 8-13 Mild Depression, 14-18 Moderate Depression, 19-22 Severe Depression, ≥23 Very Severe Depression.

  3. UPPS-P scores [ Time Frame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS ]
    Compared scores from the Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking, Positive Urgency Impulsive Behavior Scale (UPPS-P). The French version of the UPPS-P is a self-rated 45 item scale, evaluating the following components: urgency, lack of premeditation, lack of perseverance and sensation seeking. Each item is scored on a base of 4 points. Higher scores indicate higher levels of impulsivity.

  4. MADRS scores [ Time Frame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS ]
    Compared scores from the Montgomery and Asberg Depression Rating Scale (MADRS). The MADRS is clinician-rated 10 item scale, scored in a base of 6 points per item. Cutoff points are: 0-6 Asymptomatic, 7-19 Mild Depression, 20-34 Moderate Depression and >34 Severe Depression.

  5. C-SSRS scores [ Time Frame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS ]
    Compared scores from the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a clinician-rated tool that evaluates suicidal ideation and behavior. It is composed by 6 "yes/no" questions. High suicide risk is indicated when "yes" is answered to questions 4, 5 or 6.

  6. Go/No-Go task [ Time Frame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS ]
    Compared results from the experimental Go/No-Go task, assessing response inhibition.

  7. Stroop task [ Time Frame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS ]
    Compared results from the experimental Stroop task, assessing response inhibition.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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"

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498937


Contacts
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Contact: Djamila BENNABI, MD PhD +33381219007 dbennabi@chu-besancon.fr
Contact: Magali NICOLIER, PhD +33381219007 mnicolier@chu-besancon.fr

Locations
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France
CHU Besancon
Besancon, Franche-Comte, France, 25000
Contact: Djamila BENNABI, MD PhD    +33381219007    dbennabi@chu-besancon.fr   
Contact: Magali NICOLIER, PhD    +33381219007    mnicolier@chu-besancon.fr   
Principal Investigator: Djamila BENNABI, MD PhD         
Pôle Hospitalo-Universitaire de Psychiatrie du Grand Nancy
Nancy, France
Contact: Raymund Schwan, MD PhD       raymund.schwan@univ-lorraine.fr   
Centre Hospitalier Spécialisé de Rouffach
Rouffach, France
Contact: Fabrice Duval, MD       f.duval@ch-rouffach.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Djamila BENNABI, MD PhD Centre Hospitalier Universitaire de Besancon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03498937    
Other Study ID Numbers: P/2017/319
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Borderline Personality Disorder
Impulsive behavior
Suicidal behavior
Cognitive control
tDCS
Noninvasive brain stimulation
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Impulsive Behavior
Mental Disorders