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Neuromodulation by Non-invasive Brain Stimulation (NEUROMOD)

4. januar 2019 opdateret af: University Hospital, Grenoble

Neuromodulation by Non-invasive Brain Stimulation (NEUROMOD)

The main objective of this study is to estimate the effect of the neuromodulation on the behavioral performances during the access in semantics according to the age of the individuals.

Neuromodulation by non-invasive stimulation allows to explore the functioning of the brain by exciting or by inhibiting localized cortical zones. The modulation of the performances in cognitive tasks, further to the neuromodulation of these zones, allows to deduce on their functional roles.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The objective of this project is to determine the changes of behavioral performances (time of answer, percentage of correct answers) further to the neuromodulation. The specific question is to estimate the effect on the performances of access at the semantic representations of this method, according to the age. One of the hypotheses in the research on the normal ageing is the difficulty of access to these representations (fundamental process for the cognitive functions, such as the language and the memory) at the healthy elderly. By using the neuromodulation the investigators wish to explore this hypothesis and to understand if the neuromodulation can have a beneficial effect on the improvement of the behavioral performances of the elderly.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Major healthy Subject ( 18 - 85 years)
  • Right-hander
  • Signed Informed consent
  • A medical examination must be made before the participation for the research
  • Membership in or beneficiary of a national insurance scheme

Non inclusion Criteria:

  • Subject under age 18 and of more than 85 years.
  • Contraindications in the practice of MRI, TMS and tES
  • Existence of a severe affection on the general plan: cardiac, respiratory, hematological, renal, hepatic, cancerous
  • Regular taking of anxiolytic, sedative, antidepressant, neuroleptic
  • Characterized psychiatric pathology
  • Ingestion of alcohol before the examination
  • Pregnancy, parturiency or breast-feeding
  • Private person of freedom by court or administrative order, nobody being the object of a legal protective measure (under guardianship or guardianship)
  • Participation to other protocols of current search with period of exclusion or in the previous week
  • Subject which would perceive more than 4500 euros of compensation because of its participation in other searches involving the human person in 12 months preceding this study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 18-49 years group
Participants undergo 2 sessions of MRI + transcranial Magnetic Stimulation or transcranial electric stimulation + electroencephalogram. The 2 sessions are performed with an interval of 3 to 7 days.
Andet: MRI + transcranial Magnetic Stimulation
Healthy subjects undergo 2 sessions of MRI + transcranial Magnetic Stimulation + transcranial electric stimulation + electroencephalogram. The 2 sessions are performed with an interval of 3 to 7 days.
Andet: transcranial electric stimulation + electroencephalogram
Healthy subjects undergo 2 sessions of MRI + transcranial Magnetic Stimulation + transcranial electric stimulation + electroencephalogram. The 2 sessions are performed with an interval of 3 to 7 days.
Eksperimentel: 50-85 years group
Participants undergo 2 sessions of MRI + transcranial Magnetic Stimulation or transcranial electric stimulation + electroencephalogram. The 2 sessions are performed with an interval of 3 to 7 days.
Andet: MRI + transcranial Magnetic Stimulation
Healthy subjects undergo 2 sessions of MRI + transcranial Magnetic Stimulation + transcranial electric stimulation + electroencephalogram. The 2 sessions are performed with an interval of 3 to 7 days.
Andet: transcranial electric stimulation + electroencephalogram
Healthy subjects undergo 2 sessions of MRI + transcranial Magnetic Stimulation + transcranial electric stimulation + electroencephalogram. The 2 sessions are performed with an interval of 3 to 7 days.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effect of the neuromodulation on the behavioral performances during the access in semantics
Tidsramme: 3 hours
Evaluation of the changes of the behavioral performances before and after the neuromodulation by non-invasive cortical stimulation according to the age. More exactly, the investigators shall compare response times before and after neuromodulation between both age groups (18-49 years and 50-85 years), by testing the interaction between the effect of the neuromodulation and the age.
3 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Estimate the effect of the neuromodulation on the behavioral performances
Tidsramme: 3 hours
Compare the percentages of correct answers before and after neuromodulation by non-invasive cortical electric stimulation, according to the age (18-49 years vs 50-85 years).
3 hours
Estimate the effect of transcranial Electrical Stimulation (tES) on the cognitive performances by neuropsychological scores, according to the age.
Tidsramme: 3 hours
Comparison of the neuropsychological scores before and after tES, according to the age (18-49 years vs 50-85 years).
3 hours
Estimate the effect of tES on the cerebral functional activity, by comparing blood-oxygen-level dependent (BOLD ) signal or functional MRI before and after tES according to the age (18-49 years vs 50-85 years).
Tidsramme: 3 hours
The investigators extract estimates parameters (Estimated Beta weight Values) corresponding to each tES stimulation. Each session is be designed by using general linear model (Friston, 1998, statistical parametrical mapping in fMRI) defined as Ybefore tES = R1Beta1+R2Beta2 +R0Beta0 + e and Yafter tES = R1Beta1 +R2Beta2 +R0Beta0 + e, with Y = acquired BOLD signal, e = error, R1Beta1 corresponding to the task (meaning interest activation) regressor and R2Beta2 corresponding to the control (meaning no interest activation) regressor respectively convolved with the canonical hemodynamic response function (cHRf) and R0B0 corresponding to the constant regressor. Parameter estimates are calculated by extracting Beta1 and Beta2 values for each session respectively in order to compute statistical comparison (measure by subject) on the outcome measure (Beta1 before tES - Beta1 after tES).
3 hours
Estimate the effect of the Transcranial Magnetic Stimulation (TMS) on the cognitive performances by neuropsychological scores, according to the age.
Tidsramme: 3 hours
Comparison of the neuropsychological scores before and after Transcranial Magnetic Stimulation (TMS), according to the age (18-49 years vs 50-85 years).
3 hours
Estimate the effect of the TMS on the intellectual functional activity, according to the age.
Tidsramme: 3 hours
Comparison of the cerebral functional activity (electric neuronal signal, EEG) before and after TMS, according to the age (18-49 years vs 50-85 years).
3 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Grenoble

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. august 2017

Primær færdiggørelse (Forventet)

1. juni 2020

Studieafslutning (Forventet)

1. juni 2020

Datoer for studieregistrering

Først indsendt

18. april 2017

Først indsendt, der opfyldte QC-kriterier

23. maj 2017

Først opslået (Faktiske)

30. maj 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 38RC17.078
  • 2017-A00834-49 (Anden identifikator: ansm)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med MRI + transcranial Magnetic Stimulation

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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