Clinical trial NCT02402101: Effect of the Transcranial Direct Current Stimulation on the Dopaminergic Transmission in Healthy Subjects
Official title: Effect of the Transcranial Direct Current Stimulation on the Dopaminergic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transcranial Direct Current Stimulation
Dopamine
Keywords: tDCS
Dopamine
PET
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in dopamine transmission after 1 session of 20min tDCS
timeFrame: during 100min of PET scan : Baseline (20-40min), during stimulation (40-60min) and after stimulation (60-80min & 80-100min)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron Cedex
country: France
facility: Centre Hospitalier Le Vinatier
Study officials:
affiliation: CH Le Vinatier
name: Frederic Haesebaert, PH
role: PRINCIPAL_INVESTIGATOR
References: