Neuromodulation by Non-invasive Brain Stimulation

NCT ID: NCT03167931

Last Updated: 2019-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Transcranial Magnetic Stimulation Transcranial Direct Current Stimulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

outcoume measure comparison is done between both age groups (18-49 years and 50-85 years).
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

MRI + transcranial Magnetic Stimulation

Intervention Type OTHER

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.

transcranial electric stimulation + electroencephalogram

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

MRI + transcranial Magnetic Stimulation

Intervention Type OTHER

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.

transcranial electric stimulation + electroencephalogram

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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


* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU

Grenoble, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Thierry BOUGEROL

Role: CONTACT

04 76 76 54 11

Laurent TORLAY

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Thierry BOUGEROL

Role: primary

Laurent TORLAY

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23138766 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20888226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21820308 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19833552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21151809 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-A00834-49

Identifier Type: OTHER

Identifier Source: secondary_id

38RC17.078

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.