Clinical trial NCT03167931: Neuromodulation by Non-invasive Brain Stimulation
Official title: Neuromodulation by Non-invasive Brain Stimulation (NEUROMOD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Transcranial Magnetic Stimulation
Transcranial Direct Current Stimulation
Keywords: non-invasive brain stimulation
neuromodulation
semantic tasks
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: outcoume measure comparison is done between both age groups (18-49 years and 50-85 years).
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of the neuromodulation on the behavioral performances during the access in semantics
timeFrame: 3 hours
Secondary outcomes:
measure: Estimate the effect of the neuromodulation on the behavioral performances
timeFrame: 3 hours
measure: Estimate the effect of transcranial Electrical Stimulation (tES) on the cognitive performances by neuropsychological scores, according to the age.
timeFrame: 3 hours
measure: 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).
timeFrame: 3 hours
measure: Estimate the effect of the Transcranial Magnetic Stimulation (TMS) on the cognitive performances by neuropsychological scores, according to the age.
timeFrame: 3 hours
measure: Estimate the effect of the TMS on the intellectual functional activity, according to the age.
timeFrame: 3 hours
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.