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

NCT02402101 | Completed Phase 3 DMC

• 1 other identifier: 2014-A01405-42
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transcranial Direct Current Stimulation; Dopamine

Keywords

tDCS; Dopamine; PET

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

active tDCS

ACTIVE COMPARATOR

Intensity : 2mA Duration : 20 minutes ramp up/ramp down 30sec anodal tDCS applied over the left DLPFC cathodal tDCS applied over the right DLPFC

Device: Procedure: active tDCS

sham tDCS

PLACEBO COMPARATOR

Placebo built-in mode (30 sec ramp periods at the beginning and the end of the sham stimulation to mimic the somatosensory artifact of real tDCS) Same electrode montage than in the active group.

Device: Procedure: sham tDCS

Interventions

Procedure: active tDCS DEVICE

Intensity 2 mA during 20 minutes

active tDCS

Procedure: sham tDCS DEVICE

sham condition as delivered by the stimulator

Also known as: tDCS placebo

sham tDCS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non smoker
• No pyschotrope consumption
• No medical treatment
• No psychiatric or somatic (neurological, endocrine, cardiac, renal)
• Affiliated to the french social security

You may not qualify if:

• No consent
• For females : Pregnant or without birth control
• Contraindications to stimulation by tDCS or to an MRI exam
• Participation in another study using ionizing radiation in less than a year

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, 69678, France

Location

Study Officials

• Frederic Haesebaert, PH

  CH Le Vinatier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 30, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 23, 2016

Record last verified: 2016-08

Locations

FR (1)