- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03167931
Neuromodulation by Non-invasive Brain Stimulation (NEUROMOD)
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.
Panoramica dello studio
Stato
Descrizione dettagliata
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Grenoble, Francia, 38043
- Reclutamento
- CHU
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Contatto:
- Laurent TORLAY
- Email: laurent.torlay@univ-grenoble-alpes.fr
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Contatto:
- Thierry BOUGEROL
- Email: TBougerol@chu-grenoble.fr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
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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.
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.
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Sperimentale: 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.
|
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.
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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Effect of the neuromodulation on the behavioral performances during the access in semantics
Lasso di tempo: 3 hours
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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.
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3 hours
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Estimate the effect of the neuromodulation on the behavioral performances
Lasso di tempo: 3 hours
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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).
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3 hours
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Estimate the effect of transcranial Electrical Stimulation (tES) on the cognitive performances by neuropsychological scores, according to the age.
Lasso di tempo: 3 hours
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Comparison of the neuropsychological scores before and after tES, according to the age (18-49 years vs 50-85 years).
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3 hours
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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).
Lasso di tempo: 3 hours
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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).
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3 hours
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Estimate the effect of the Transcranial Magnetic Stimulation (TMS) on the cognitive performances by neuropsychological scores, according to the age.
Lasso di tempo: 3 hours
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Comparison of the neuropsychological scores before and after Transcranial Magnetic Stimulation (TMS), according to the age (18-49 years vs 50-85 years).
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3 hours
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Estimate the effect of the TMS on the intellectual functional activity, according to the age.
Lasso di tempo: 3 hours
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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).
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3 hours
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
- Zimerman M, Hummel FC. Non-invasive brain stimulation: enhancing motor and cognitive functions in healthy old subjects. Front Aging Neurosci. 2010 Dec 1;2:149. doi: 10.3389/fnagi.2010.00149. eCollection 2010.
- Holland R, Leff AP, Josephs O, Galea JM, Desikan M, Price CJ, Rothwell JC, Crinion J. Speech facilitation by left inferior frontal cortex stimulation. Curr Biol. 2011 Aug 23;21(16):1403-7. doi: 10.1016/j.cub.2011.07.021. Epub 2011 Aug 4.
- Monti A, Ferrucci R, Fumagalli M, Mameli F, Cogiamanian F, Ardolino G, Priori A. Transcranial direct current stimulation (tDCS) and language. J Neurol Neurosurg Psychiatry. 2013 Aug;84(8):832-42. doi: 10.1136/jnnp-2012-302825. Epub 2012 Nov 8.
- Liuzzi G, Freundlieb N, Ridder V, Hoppe J, Heise K, Zimerman M, Dobel C, Enriquez-Geppert S, Gerloff C, Zwitserlood P, Hummel FC. The involvement of the left motor cortex in learning of a novel action word lexicon. Curr Biol. 2010 Oct 12;20(19):1745-51. doi: 10.1016/j.cub.2010.08.034. Epub 2010 Sep 30.
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 38RC17.078
- 2017-A00834-49 (Altro identificatore: ansm)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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