Healthy VolunteersRC-TMSNCT02596789
Cortical Excitability Using Transcranial Magnetic Stimulation and Neuronavigation Device
A study testing TMS "Magpro®, Magventure Inc" device in people with Healthy Volunteers, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TMS "Magpro®, Magventure Inc" device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female
- age 18-75
- signed informed consent
- normal physical examination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Psychiatry & Neurology - University Hospital Grenoble
Grenoble, 38000
About this study
Official title: Study of Cortical Excitability in Healthy Subjects With Transcranial Magnetic Stimulation (TMS) and a Neuronavigation Device
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.
- Conditions
- Healthy Volunteers
- Being tested
- TMS "Magpro®, Magventure Inc" device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS "Magpro®, Magventure Inc" deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| state dependency TMS | Other | TMS performed at rest and during a cognitive/emotional task Receives: Device: TMS "Magpro®, Magventure Inc" device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Participants will be followed for an expected average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startJun 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry BOUGEROL, MD, PhD, Principal investigator, University of Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596789
- Sponsor's protocol ID
- 2012-A00316-37
- Acronym
- RC-TMS
- Status last verified
- May 2017
- First submitted
- 23 Jul 2014
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cortical Excitability in Healthy Subjects With Transcranial Magnetic Stimulation (TMS) and a Neuronavigation Device
- ClinicalTrials.gov ID
- NCT02596789
- Acronym / sponsor ID
- RC-TMS / 2012-A00316-37
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| state dependency TMS | Other | Device: TMS "Magpro®, Magventure Inc" deviceTMS performed at rest and during a cognitive/emotional task |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or female
- age 18-75
- signed informed consent
- normal physical examination
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMS "Magpro®, Magventure Inc" device | Device | state dependency TMS |
Primary outcome
Amplitudes of Motor evoked Potentials (µV) for ICI and ICF.
Time frame: Participants will be followed for an expected average of one month
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.
Durations of Cortical Silent Period (ms)
Time frame: Participants will be followed for an expected average of one month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry BOUGEROL, MD, PhD principal investigator
University of Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS "Magpro®, Magventure Inc" device in people with Healthy Volunteers, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitudes of Motor evoked Potentials (µV) for ICI and ICF. (time frame: Participants will be followed for an expected average of one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017; AzTrials last refreshed its copy on 30 Oct 2026.