Effect of the Transcranial Direct Current Stimulation on the Dopaminergic Transmission in Healthy Subjects

Transcranial Direct Current Stimulation Clinical Trial

— DOPA-STIM  

Official title:

Effect of the Transcranial Direct Current Stimulation on the Dopaminergic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402101
• Other study ID #: 2014-A01405-42
• Status: Completed
• Phase: Phase 3
• First received: March 18, 2015
• Last updated: August 22, 2016
• Start date: February 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Transcranial direct current stimulation (tDCS) is a technique that is emerging as a prospective therapy for neurologic, psychiatric and addictive disorders. Specifically, anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) is associated with improvement of cognitive functions and mood. Despite an increased use in clinical settings, tDCS suffers from limitations, especially regarding the strength and the duration of therapeutic effects. Strategies to optimize the conditions for tDCS application suffer from the lack of knowledge about its neurophysiological impact. Moreover, tDCS is increasingly used in private settings through commercial apparatus and tutorials to make a "do-it-yourself" device delivering tDCS now available on the Internet. This private use worries neuroscientists and health authorities. Even if the general impression is that, in controlled conditions, tDCS is safe with only mild and transient adverse effects, whether and how tDCS could be used for enhancing cognition in healthy subjects are needed to investigate in more detail. The investigators believe that a better understanding of some neurobiological effects of tDCS is crucial to further tailor tDCS for experimental and therapeutic applications and to define recommendations for a private use.

As the cortex is densely connected with basal ganglia areas, including dopaminergic areas, tDCS is probably not only capable to target cortical but also subcortical structures remote from the stimulation sites. Some studies suggest that cortical stimulation by other approaches, such as transcranial magnetic stimulation (rTMS) leads to an increased dopaminergic transmission. The involvement of dopaminergic systems in tDCS effects has been investigated only indirectly in pharmacological studies. Thus, the direct effect of the DLPFC stimulation by tDCS on dopaminergic transmission is still unknown.

The aim of this project is to reveal the online impact of a single-session of tDCS applied bilaterally over the DLPFC in healthy subjects on the dopaminergic transmission measured by PET, combined with the [11C]raclopride bolus-plus-continuous-infusion method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Non smoker

• No pyschotrope consumption

• No medical treatment

• No psychiatric or somatic (neurological, endocrine, cardiac, renal)

• Affiliated to the french social security

Exclusion Criteria:

• No consent

• For females : Pregnant or without birth control

• Contraindications to stimulation by tDCS or to an MRI exam

• Being in an exclusion period or over the annual compensation ceiling

• Participation in another study using ionizing radiation in less than a year

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dopamine
• Transcranial Direct Current Stimulation

Intervention

Device:
• Procedure: active tDCS
Intensity 2 mA during 20 minutes
• Procedure: sham tDCS
sham condition as delivered by the stimulator

Locations

Country	Name	City	State
France	Centre Hospitalier Le Vinatier	Bron Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in dopamine transmission after 1 session of 20min tDCS	Measure of the Binding Ratio defined as the ratio of : region of interest / cerebellum activities)	during 100min of PET scan : Baseline (20-40min), during stimulation (40-60min) and after stimulation (60-80min & 80-100min)	No