- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03056170
Neurophysiological Impact of a Fronto-temporal tDCS Stimulation in Healthy Subjects: a Multimodal Imaging Approach (COMBI-STIM)
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:
- the "normal brain" and further deficient mechanisms underlying schizophrenia as well as neurological disorders.
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
Přehled studie
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Bron, Francie, 69500
- Le Vinatier
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: 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.
|
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.
|
Falešný srovnávač: 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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in dopamine transmission induced by 1 session of 30min tDCS
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in spontaneous functional connectivity (using rs fMRI) during and after 1 session of 30min tDCS
Časové okno: - 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
Časové okno: - 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
Časové okno: - 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Frédéric Haesebaert, MD, Le Vinatier
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 69HCL16_0682
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Zdravý
-
University of ZurichDokončenoOutcome Assessment, Health CareŠvýcarsko
-
University of BernUniversity Hospital Inselspital, BerneDokončenoNeuroscience of Dreaming, HealthŠvýcarsko
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development... a další spolupracovníciAktivní, ne náborPreventivní zdravotní služby (PREV HEALTH SERV)Spojené státy
-
Queens College, The City University of New YorkNáborZveřejnění článků předložených American Journal of Public HealthSpojené státy
-
Kliniek ViaSanaSt. Anna Ziekenhuis, Geldrop, NetherlandsDokončenoBolest | Užívání opioidů | Totální náhrada kolena | Aplikace E-healthHolandsko
-
Istanbul University - Cerrahpasa (IUC)NáborKardiochirurgie, Srdeční chirurgie, Výuka propouštění, Ošetřovatelství, Telenutriční péče, m-Health, Kvalita života, ZotaveníKrocan
-
FIDMAG Germanes HospitalàriesUniversity of BarcelonaZatím nenabírámePorucha duševního zdraví | Duševní zdraví wellness 1 | Role sestry | Care Acceptor, Health | Vztah, sestra pacienta
-
University of AarhusRegion MidtJylland Denmark; Tryg Danmark; Randers Municipality, DenmarkNeznámýKardiovaskulární onemocnění | Podpora zdraví | Duševní zdraví | Fyzická nečinnost | Self-reported Quality of HealthDánsko
-
Yorkshire Ambulance Service NHS TrustUniversity of BradfordZatím nenabírámeTestování Point of Care | Klinické rozhodování | Komunitní urgentní a pohotovostní péče | Allied Health Professional
-
4Life Research, LLCDokončenoSin Health | Hydratace pleti | Kožní vrásky | Kožní porfyriny | Červené skvrny na kůži obličeje | Červená vaskulatura kůže obličejeSpojené státy
Klinické studie na real tDCS
-
The Hong Kong Polytechnic UniversityThe University of Hong Kong; University of Magdeburg; University of WaterlooNábor
-
National University Hospital, SingaporeNational University Health System, Singapore; Agency for Science, Technology...Dokončeno
-
University of South CarolinaMedical University of South Carolina; National Institute on Deafness and Other...Dokončeno
-
University Hospital of FerraraNábor
-
University Hospital of FerraraDokončeno
-
University of MinnesotaZatím nenabíráme
-
Arizona State UniversityUniversidad Autonoma de Nuevo Leon; Instituto Nacional Psiquiatrico de México... a další spolupracovníciDokončeno
-
University of Southern CaliforniaDokončenoDiabetes MellitusSpojené státy
-
Institut za Rehabilitaciju Sokobanjska BeogradDokončeno
-
IRCCS Centro San Giovanni di Dio FatebenefratelliNábor