DOPA-STIM: Effect of the Transcranial Direct Current Stimulation on the Dopaminergic Transmission in Healthy Subjects

Sponsor

Hôpital le Vinatier (Other)

Overall Status

Completed

CT.gov ID

NCT02402101

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transcranial Direct Current Stimulation Dopamine	Device: Procedure: active tDCS Device: Procedure: sham tDCS	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Effect of the Transcranial Direct Current Stimulation on the Dopaminergic

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: active tDCS 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 Intensity 2 mA during 20 minutes
Placebo Comparator: sham tDCS 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 sham condition as delivered by the stimulator Other Names: tDCS placebo

Arm

Intervention/Treatment

Active Comparator: active tDCS

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

Intensity 2 mA during 20 minutes

Placebo Comparator: sham tDCS

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

sham condition as delivered by the stimulator

Other Names:

tDCS placebo

Outcome Measures

Primary Outcome Measures

Change in dopamine transmission after 1 session of 20min tDCS [during 100min of PET scan : Baseline (20-40min), during stimulation (40-60min) and after stimulation (60-80min & 80-100min)]
Measure of the Binding Ratio defined as the ratio of : region of interest / cerebellum activities)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Le Vinatier	Bron Cedex		France	69678

Sponsors and Collaborators

Hôpital le Vinatier

Investigators

Principal Investigator: Frederic Haesebaert, PH, CH Le Vinatier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hôpital le Vinatier

ClinicalTrials.gov Identifier:

NCT02402101

Other Study ID Numbers:

2014-A01405-42

First Posted:

Mar 30, 2015

Last Update Posted:

Aug 23, 2016

Last Verified:

Aug 1, 2016

Keywords provided by Hôpital le Vinatier

tDCS

Dopamine

PET

Study Results

No Results Posted as of Aug 23, 2016