Effects of tDCS on Impulsiveness Among People Suffering From Borderline Personality Disorder (TIMBER)
Primary Purpose
Borderline Personality Disorder, Impulsive Behavior
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Active tDCS
Sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline Personality Disorder, Impulsive behavior, Suicidal behavior, Cognitive control, tDCS, Noninvasive brain stimulation
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"
Sites / Locations
- CHU Besancon
- Pôle Hospitalo-Universitaire de Psychiatrie du Grand Nancy
- Centre Hospitalier Spécialisé de Rouffach
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
Subjects suffering from Borderline Personality Disorder randomly assigned to start the trial by 10 active tDCS sessions, followed by 10 sham tDCS sessions
Subjects suffering from Borderline Personality Disorder randomly assigned to start the trial by 10 sham tDCS sessions, followed by 10 active tDCS sessions
Outcomes
Primary Outcome Measures
EPs during BART
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
BIS-10 scores
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.
HDRS scores
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.
UPPS-P scores
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.
MADRS scores
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.
C-SSRS scores
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.
Go/No-Go task
Compared results from the experimental Go/No-Go task, assessing response inhibition.
Stroop task
Compared results from the experimental Stroop task, assessing response inhibition.
Full Information
NCT ID
NCT03498937
First Posted
April 9, 2018
Last Updated
March 6, 2019
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT03498937
Brief Title
Effects of tDCS on Impulsiveness Among People Suffering From Borderline Personality Disorder
Acronym
TIMBER
Official Title
Effet de la tDCS Sur l'impulsivité Chez Les Personnes Souffrant d'un Trouble Borderline : TIMBER
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2019 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Impulsive Behavior
Keywords
Borderline Personality Disorder, Impulsive behavior, Suicidal behavior, Cognitive control, tDCS, Noninvasive brain stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Subjects suffering from Borderline Personality Disorder randomly assigned to start the trial by 10 active tDCS sessions, followed by 10 sham tDCS sessions
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Subjects suffering from Borderline Personality Disorder randomly assigned to start the trial by 10 sham tDCS sessions, followed by 10 active tDCS sessions
Intervention Type
Device
Intervention Name(s)
Active tDCS
Other Intervention Name(s)
Starstim® (Neuroelectrics, Spain)
Intervention Description
10 active tDCS sessions (2 sessions/day for 5 days, 30 min each, 2 mA) applied to the dlPFC
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Other Intervention Name(s)
Starstim® (Neuroelectrics, Spain)
Intervention Description
10 sham tDCS sessions (2 sessions/day for 5 days, 30 min each, 0 mA) applied to the dlPFC
Primary Outcome Measure Information:
Title
EPs during BART
Description
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.
Time Frame
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Secondary Outcome Measure Information:
Title
BIS-10 scores
Description
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.
Time Frame
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Title
HDRS scores
Description
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.
Time Frame
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Title
UPPS-P scores
Description
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.
Time Frame
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Title
MADRS scores
Description
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.
Time Frame
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Title
C-SSRS scores
Description
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.
Time Frame
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Title
Go/No-Go task
Description
Compared results from the experimental Go/No-Go task, assessing response inhibition.
Time Frame
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Title
Stroop task
Description
Compared results from the experimental Stroop task, assessing response inhibition.
Time Frame
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Djamila BENNABI, MD PhD
Phone
+33381219007
Email
dbennabi@chu-besancon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Magali NICOLIER, PhD
Phone
+33381219007
Email
mnicolier@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Djamila BENNABI, MD PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Besancon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besancon
City
Besancon
State/Province
Franche-Comte
ZIP/Postal Code
25000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Djamila BENNABI, MD PhD
Phone
+33381219007
Email
dbennabi@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Magali NICOLIER, PhD
Phone
+33381219007
Email
mnicolier@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Djamila BENNABI, MD PhD
Facility Name
Pôle Hospitalo-Universitaire de Psychiatrie du Grand Nancy
City
Nancy
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymund Schwan, MD PhD
Email
raymund.schwan@univ-lorraine.fr
Facility Name
Centre Hospitalier Spécialisé de Rouffach
City
Rouffach
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice Duval, MD
Email
f.duval@ch-rouffach.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32368793
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.
Results Reference
derived
PubMed Identifier
31182143
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.
Results Reference
derived
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Effects of tDCS on Impulsiveness Among People Suffering From Borderline Personality Disorder
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