Effects of tDCS on Impulsiveness Among People Suffering From Borderline Personality Disorder
TIMBER
Effet de la tDCS Sur l'impulsivité Chez Les Personnes Souffrant d'un Trouble Borderline : TIMBER
1 other identifier
interventional
50
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2018
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 7, 2019
April 1, 2018
1.1 years
April 9, 2018
March 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
BIS-10 scores
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
HDRS scores
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
UPPS-P scores
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
MADRS scores
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
C-SSRS scores
Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS
- +2 more secondary outcomes
Study Arms (2)
Group 1
EXPERIMENTALSubjects suffering from Borderline Personality Disorder randomly assigned to start the trial by 10 active tDCS sessions, followed by 10 sham tDCS sessions
Group 2
EXPERIMENTALSubjects suffering from Borderline Personality Disorder randomly assigned to start the trial by 10 sham tDCS sessions, followed by 10 active tDCS sessions
Interventions
10 active tDCS sessions (2 sessions/day for 5 days, 30 min each, 2 mA) applied to the dlPFC
10 sham tDCS sessions (2 sessions/day for 5 days, 30 min each, 0 mA) applied to the dlPFC
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
CHU Besancon
Besançon, Franche-Comte, 25000, France
Pôle Hospitalo-Universitaire de Psychiatrie du Grand Nancy
Nancy, France
Centre Hospitalier Spécialisé de Rouffach
Rouffach, France
Related Publications (2)
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.
PMID: 32368793DERIVEDTeti 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.
PMID: 31182143DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Djamila BENNABI, MD PhD
Centre Hospitalier Universitaire de Besancon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2018
First Posted
April 17, 2018
Study Start
May 1, 2019
Primary Completion
June 1, 2020
Study Completion
December 1, 2020
Last Updated
March 7, 2019
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share