Neuromodulation by Non-invasive Brain Stimulation
NEUROMOD
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Aug 2017
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2017
CompletedStudy Start
First participant enrolled
August 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJanuary 8, 2019
January 1, 2019
2.8 years
April 18, 2017
January 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of the neuromodulation on the behavioral performances during the access in semantics
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
Secondary Outcomes (5)
Estimate the effect of the neuromodulation on the behavioral performances
3 hours
Estimate the effect of transcranial Electrical Stimulation (tES) on the cognitive performances by neuropsychological scores, according to the age.
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).
3 hours
Estimate the effect of the Transcranial Magnetic Stimulation (TMS) on the cognitive performances by neuropsychological scores, according to the age.
3 hours
Estimate the effect of the TMS on the intellectual functional activity, according to the age.
3 hours
Study Arms (2)
18-49 years group
EXPERIMENTALParticipants 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.
50-85 years group
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU
Grenoble, 38043, France
Related Publications (5)
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.
PMID: 23138766BACKGROUNDLiuzzi 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.
PMID: 20888226BACKGROUNDHolland 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.
PMID: 21820308BACKGROUNDRossi 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.
PMID: 19833552BACKGROUNDZimerman 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.
PMID: 21151809BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Each participant is included for 2 neuromodulation sessions: one session where neurostimulation is effective, one session where neurostimulation is simulated. Sessions are performed blind for the participant and the outcome assessor. Sessions order is randomized for each participant (no arm randomization).
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2017
First Posted
May 30, 2017
Study Start
August 31, 2017
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
January 8, 2019
Record last verified: 2019-01