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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03498937
Other study ID # P/2017/319
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2019
Est. completion date December 2020

Study information

Verified date April 2018
Source Centre Hospitalier Universitaire de Besancon
Contact Djamila BENNABI, MD PhD
Phone +33381219007
Email dbennabi@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Device:
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

Locations

Country Name City State
France CHU Besancon Besancon Franche-Comte
France Pôle Hospitalo-Universitaire de Psychiatrie du Grand Nancy Nancy
France Centre Hospitalier Spécialisé de Rouffach Rouffach

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Secondary 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. Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Secondary 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. Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Secondary 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. Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Secondary 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. Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Secondary 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. Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Secondary Go/No-Go task Compared results from the experimental Go/No-Go task, assessing response inhibition. Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
Secondary Stroop task Compared results from the experimental Stroop task, assessing response inhibition. Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
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