Efficacy of transcranial direct current stimulation in reducing impulsivity in borderline personality disorder (TIMBER): study protocol of a randomized controlled clinical trial.
Borderline personality disorder
Dorsolateral prefrontal cortex
Impulsivity
Risk-taking
Transcranial direct current stimulation
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
10 Jun 2019
10 Jun 2019
Historique:
received:
05
11
2018
accepted:
11
05
2019
entrez:
12
6
2019
pubmed:
12
6
2019
medline:
28
12
2019
Statut:
epublish
Résumé
Impulsivity is a core feature of borderline personality disorder (BPD) and is closely related to suicide risk and destructive and aggressive behaviors. Although transcranial direct current stimulation (tDCS) has shown its promising effects as an intervention to modulate impulsivity, no study has explored its potential regarding BPD. This is a multicenter, crossover, double-blind study comparing active versus sham tDCS (2 mA, 30 min), applied over the dorsolateral prefrontal cortex for five consecutive days in 50 BPD patients. Participants will be assessed for impulsivity, depressive symptoms, and suicide risk. The main efficacy criteria on reduction of impulsivity will be the amplitude variation of one specific evoked potential detected by electroencephalography (EEG) during the balloon analogue risk task. Baseline measures will be compared to scores obtained immediately after sessions, then 12 and 30 days later. This study investigates the safety and effects of tDCS, which may have a significant impact on impulsivity in patients with BPD and may be useful to reduce risky behaviors. ClinicalTrials.gov, NCT03498937 . Registered on 17 April 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Impulsivity is a core feature of borderline personality disorder (BPD) and is closely related to suicide risk and destructive and aggressive behaviors. Although transcranial direct current stimulation (tDCS) has shown its promising effects as an intervention to modulate impulsivity, no study has explored its potential regarding BPD.
METHODS/DESIGN
METHODS
This is a multicenter, crossover, double-blind study comparing active versus sham tDCS (2 mA, 30 min), applied over the dorsolateral prefrontal cortex for five consecutive days in 50 BPD patients. Participants will be assessed for impulsivity, depressive symptoms, and suicide risk. The main efficacy criteria on reduction of impulsivity will be the amplitude variation of one specific evoked potential detected by electroencephalography (EEG) during the balloon analogue risk task. Baseline measures will be compared to scores obtained immediately after sessions, then 12 and 30 days later.
DISCUSSION
CONCLUSIONS
This study investigates the safety and effects of tDCS, which may have a significant impact on impulsivity in patients with BPD and may be useful to reduce risky behaviors.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, NCT03498937 . Registered on 17 April 2018.
Identifiants
pubmed: 31182143
doi: 10.1186/s13063-019-3427-z
pii: 10.1186/s13063-019-3427-z
pmc: PMC6558822
doi:
Banques de données
ClinicalTrials.gov
['NCT03498937']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
347Subventions
Organisme : Centre Hospitalier Universitaire de Besancon (FR) / French Eastern Interregional Group of Clinical Research and Innovation (GIRCI Est)
ID : APJ 2016, ID P/2017/319
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