Borderline Personality Disorder Clinical Trial
— TIMBEROfficial title:
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 2020 |
Est. primary completion date | June 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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" |
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 |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Besancon |
France,
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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