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Neurophysiological Impact of a Fronto-temporal tDCS Stimulation in Healthy Subjects: a Multimodal Imaging Approach (COMBI-STIM)

6 juillet 2017 mis à jour par: Hospices Civils de Lyon

Neurophysiological Impact of a Fronto-temporal Transcranial Direct Current Stimulation (tDCS) in Healthy Subjects: a Multimodal Imaging Approach

tDCS is a technique emerging as a prospective therapy for neurologic, psychiatric and addictive disorders. Specifically, fronto-temporal tDCS, with anodal stimulation over the left dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation over the left temporo-parietal junction (TPJ), has been reported to reduce treatment-resistant auditory hallucinations (AH), negative symptoms and insight of the illness in schizophrenia. However, despite an increasing use in clinical settings, tDCS suffers from limitations, especially regarding the strength and the duration of therapeutic effects.

Some imaging reports suggest that tDCS effects are not restricted to the brain areas located under the electrodes, but spread through distributed cortical networks functionally connected with the targets and reach subcortical areas. Overall, these studies suggest that tDCS modulates functional connectivity within and across resting-state networks and brain activity. However, these effects are currently described at different levels depending on the imaging technique used. Moreover, the majority of studies have focused on motor cortex stimulation, while the specific effects of fronto-temporal tDCS are scarce. Finally, effects of the stimulation applied online are rarely inspected.

According to the therapeutic effects of fronto-temporal tDCS on schizophrenia and the dopaminergic pathophysiological hypothesis of schizophrenia, the effect of fronto-temporal tDCS on dopaminergic transmission is of major interest. As the cortex is densely connected with basal ganglia areas, tDCS effects are probably capable to reach subcortical dopaminergic areas. Indeed, recent fMRI studies highlighted subcortical effects of tDCS applied at the cortical level including modulations of cortico-striatal and thalamo-cortical functional connectivity. In addition, some studies suggest that cortical stimulation by other approaches, such as transcranial magnetic stimulation (rTMS) modulates dopaminergic transmission. However, tDCS effects on dopaminergic transmission have been investigated only indirectly.

Finally, information about biological effects of tDCS is scattered and creating a coherent ensemble is a mandatory and critical step to understand the mechanisms of action of tDCS.

According to the hypothesis that fronto-temporal tDCS modulates brain activity, connectivity and dopaminergic transmission, the aim of this project is to reveal the combined neurobiological impact of an online single session of fronto-temporal tDCS in a unique experiment by developing a simultaneous multimodal imaging approach (PET-MRI). The online implementation of the stimulation will allow deciphering changes induced during and after stimulation. As a first step before investigating patients with schizophrenia, healthy subjects will be involved in the present study.

The distributed changes will be explored at rest through:

  • Spontaneous functional connectivity assessed by functional magnetic resonance imagery (fMRI).
  • Brain activity assessed by cerebral blood flow quantitatively and directly measured by arterial spin labelling (ASL).
  • Connectivity assessed by diffusion tensor imaging (DTI).
  • Specific and localized dopaminergic transmission evaluated by positron emission tomography (PET) using dopaminergic D2 subtype receptor availability via [11C]raclopride binding.

The pioneering aspects of the project are to use an innovative simultaneous multimodal imaging system, adopt the tDCS montage used in our validated therapeutic context and apply tDCS online. We expect that our unique approach will provide an imaging biomarker essential to improve our understanding of:

  1. the "normal brain" and further deficient mechanisms underlying schizophrenia as well as neurological disorders.

  2. neurobiological effects of tDCS in order to:

    • Bring key element of the proof of concept of tDCS
    • Optimize tDCS in a therapeutic context
    • Suggest a marker of the therapeutic response

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

37

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • France
      • Bron, France, 69500
        • Le Vinatier

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 45 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • non smoker
  • right handed
  • non psychotropic consumption
  • no medical treatment except oral contraception
  • no psychiatric or somatic (neurological, endocrine, cardiac, renal) disorders
  • affiliated to the French social security

Exclusion Criteria:

  • No Consent formed signed
  • For female participants : pregnancy
  • contraindications to stimulation by tDCS or to an MRI exam
  • being in an exclusion period or over the annual compensation threshold
  • participation in another study using ionizing radiation in less than a year

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Active tDCS
The anode is placed over the left dorsolateral prefrontal cortex (DLPFC) and the cathode is placed over the left temporo-parietal cortex (TPJ) In active stimulation with a Transcranial Direct Current Stimulation, the device will deliver a charge of 1 mA for 30 minutes.
Dispositif: real tDCS
In active stimulation, the "Transcranial Direct Current Stimulation" device will produce a direct current of 1 mA from one electrode to the other for 30 min with a ramp up at the beginning and a ramp down at the end of the stimulation of 30 s. The sham or active mode is chosen by a numeric code.
Comparateur factice: Sham tDCS
In sham stimulation, with a Transcranial Direct Current Stimulation, no current will be delivered from one electrode to the other except one 30 s ramp up and down at the beginning and one at the end of the sham stimulation duration (30 min) Same electrode montage than in the active group.
Dispositif: real tDCS
In active stimulation, the "Transcranial Direct Current Stimulation" device will produce a direct current of 1 mA from one electrode to the other for 30 min with a ramp up at the beginning and a ramp down at the end of the stimulation of 30 s. The sham or active mode is chosen by a numeric code.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in dopamine transmission induced by 1 session of 30min tDCS
Délai: Continuous measure during 110min of PET scan
Measure of the Binding Ratio of the radiomarker defined as the ratio of : region of interest / cerebellum activities
Continuous measure during 110min of PET scan

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in spontaneous functional connectivity (using rs fMRI) during and after 1 session of 30min tDCS
Délai: - Before stimulation : t+15 to t+28min - During stimulation : t+45 to t+58min - After stimulation : t+76 to t+89min
The impact of tDCS will be analysed using functional connectivity maps seeded from stimulated regions and from areas belonging to specific networks. Data will be preprocessed and analyzed using specific toolbox.
- Before stimulation : t+15 to t+28min - During stimulation : t+45 to t+58min - After stimulation : t+76 to t+89min
Change in cerebral blood flow (using ASL) during and after 1 session of 30min tDCS
Délai: - Before stimulation : t+30 to t+36min - During stimulation : t+60 to t+66min - After stimulation : t+91 to t+97min
The impact of tDCS will be analysed using quantitative CBF maps seeded from stimulated regions and from areas belonging to specific networks. Data will be preprocessed and analyzed using specific toolbox.
- Before stimulation : t+30 to t+36min - During stimulation : t+60 to t+66min - After stimulation : t+91 to t+97min
Change in structural connectivity (using DTI) after 1 session of 30min tDCS
Délai: - Before stimulation : t+0 to t+10min - After stimulation : t+100 to t+110min
The impact of tDCS will be analysed using a tractography-based analysis. Data will be preprocessed and analyzed using specific toolbox.
- Before stimulation : t+0 to t+10min - After stimulation : t+100 to t+110min

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospices Civils de Lyon

Les enquêteurs

  • Chercheur principal: Frédéric Haesebaert, MD, Le Vinatier

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

13 novembre 2015

Achèvement primaire (Réel)

19 avril 2017

Achèvement de l'étude (Réel)

20 juin 2017

Dates d'inscription aux études

Première soumission

8 février 2017

Première soumission répondant aux critères de contrôle qualité

14 février 2017

Première publication (Réel)

17 février 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 juillet 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 juillet 2017

Dernière vérification

1 juillet 2017

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 69HCL16_0682

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur En bonne santé

Essais cliniques sur real tDCS

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