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

March 6, 2019 updated by: Centre Hospitalier Universitaire de Besancon

Effet de la tDCS Sur l'impulsivité Chez Les Personnes Souffrant d'un Trouble Borderline : TIMBER

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Franche-Comte
      • Besancon, Franche-Comte, France, 25000
        • CHU Besançon
        • Contact:
        • Principal Investigator:
          • Djamila BENNABI, MD PhD

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

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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"

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Starstim® (Neuroelectrics, Spain)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
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.
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
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.
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
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.
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
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.
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
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.
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
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.
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Djamila BENNABI, MD PhD, Centre Hospitalier Universitaire de Besançon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2017/319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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