NCT02596789

Brief Summary

This study has two main goals :

  • to investigate the impact of aging on cortical excitability (CE)
  • to investigate the impact of "state dependency" on CE, using a cognitive task and an emotional one. A Neuronavigation system of transcranial magnetic stimulation is used, and electromyographic response are recorded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2014

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

4 years

First QC Date

July 23, 2014

Last Update Submit

May 3, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Amplitudes of Motor evoked Potentials (µV) for ICI and ICF.

    Motor Evoked Potential (MEP) from the first dorsal interosseous are register during the stimulations. Intracortical Inhibition (ICI) and Facilitation (ICF) are a paired-pulse TMS measure of cortical excitability. A short Interval interstimuli (2ms) leads to a cortical inhibition, which reflects the GABAergic neurotransmission; whereas a longer interval interstimuli leads to a cortical facilitation, which reflects glutamatergic neurotransmission.

    Participants will be followed for an expected average of one month

  • Durations of Cortical Silent Period (ms)

    Cortical Silent Period (CSP) is a single-pulse TMS measure of cortical inhibition, stimulations are applied while subjects are exerting a muscular contraction of the thum-index pinch and lead to a muscular cancellation. Duration of this silence is measured.

    Participants will be followed for an expected average of one month

Study Arms (1)

state dependency TMS

OTHER

TMS performed at rest and during a cognitive/emotional task

Device: TMS "Magpro®, Magventure Inc" device

Interventions

state dependency TMS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female
  • age 18-75
  • signed informed consent
  • normal physical examination

You may not qualify if:

  • less 18 or more 75 years of age
  • contra indication to TMS: epilepsia or seizures, metallic head devices, cardiac pacemaker, pregnancy, jet lag or severe insomnia the night before
  • severe physical disease
  • treatment with psychotropic drugs
  • overt psychiatric disease
  • alcohol consumption before the examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry & Neurology - University Hospital Grenoble

Grenoble, 38000, France

Location

Study Officials

  • Thierry BOUGEROL, MD, PhD

    University of Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2014

First Posted

November 4, 2015

Study Start

June 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations