" Effect of Affordance of Objects on the Memory: Study in Transcranial Magnetic Stimulation " (SIMULANG-TMS)

April 26, 2017 updated by: Centre Hospitalier St Anne

" Effect of Affordance of Objects on the Memory: Study in Transcranial Magnetic Stimulation " (SIMULANG-TMS)

The purpose of this study is determine the involvement of motor system in the memory of manipulable objects. The idea is to stimulate the ventral premotor cortex with transcranial magnetic stimulation to see whether this stimulation will affect memory of manipulable objects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Embodied cognition claims that representations shares processing resources with sensorimotor systems. More specifically, it has been proposed that language comprehension relies on internal simulation of the meaning. For instance, numerous studies have shown that the processing of action-related concepts involve a motor activation similar to when the action is actually performed. However, even if those studies show clearly that action-related concepts involve a motor activation, such activations may be incidental to the activation of their representations, rather than part of it. Another way to show that this motor component takes part in the representation of manipulable objetcs is to investigate whether an impairment of motor system would impair the memory of manipulable object. In this study, investigators will use Transcranial Magnetic Stimulation (TMS) to stimulate ventral premotor cortex (PMv) to see whether this stimulation will affect memory of manipulable objects, but not memory of nonmanipulable objects. For this purpose, three TMS conditions will be assessed: cTBS to inhibit the motor cortex, iTBS to excite the motor cortex, and a SHAM condition as control.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 and 35 years
  • Right-handers (score between 70 and 100 on the scale of Edinburgh)
  • Native language : French
  • Not depressed (score lower than 14 in the BDI)
  • health insurance
  • Consent

Exclusion Criteria:

  • Psychiatric family history up to the second degree
  • Medical treatment, in particular psychotropic being able to affect the memory and the attention
  • view or hearing disorders (not compensated)
  • neurological histories (epilepsy, alcoholism in particular) or psychiatric or important memory complaints
  • Contraindications for the SMT
  • contraindications in the MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Group iTBS-cTBS-SHAM
PMv stimulation (iTBS) at session 2, PMv inhibition (cTBS) at session 3, and control (SHAM) at session 4
Other: PMv stimulation (iTBS)
PMv stimulation (iTBS)
Other: PMv inhibition (cTBS)
PMv inhibition (cTBS)
Other: Control (SHAM)
Control (SHAM)
Other: Group iTBS-SHAM-cTBS
PMv stimulation (iTBS) at session 2, control (SHAM) at session 3, and PMv inhibition (cTBS) at session 4
Other: PMv stimulation (iTBS)
PMv stimulation (iTBS)
Other: PMv inhibition (cTBS)
PMv inhibition (cTBS)
Other: Control (SHAM)
Control (SHAM)
Other: Group cTBS-iTBS-SHAM
PMv inhibition (cTBS) at session 2, PMv stimulation (iTBS) at session 3, and control (SHAM) at session 4
Other: PMv stimulation (iTBS)
PMv stimulation (iTBS)
Other: PMv inhibition (cTBS)
PMv inhibition (cTBS)
Other: Control (SHAM)
Control (SHAM)
Other: Group cTBS-SHAM-iTBS
PMv inhibition (cTBS) at session 2, control (SHAM) at session 3, and PMv stimulation (iTBS) at session 4
Other: PMv stimulation (iTBS)
PMv stimulation (iTBS)
Other: PMv inhibition (cTBS)
PMv inhibition (cTBS)
Other: Control (SHAM)
Control (SHAM)
Other: Group SHAM-iTBS-cTBS
control (SHAM) at session 2, PMv stimulation (iTBS) at session 3, and PMv inhibition (cTBS) at session 4
Other: PMv stimulation (iTBS)
PMv stimulation (iTBS)
Other: PMv inhibition (cTBS)
PMv inhibition (cTBS)
Other: Control (SHAM)
Control (SHAM)
Other: Group SHAM-cTBS-iTBS
control (SHAM) at session 2, PMv inhibition (cTBS) at session 3, and PMv stimulation (iTBS) at session 4
Other: PMv stimulation (iTBS)
PMv stimulation (iTBS)
Other: PMv inhibition (cTBS)
PMv inhibition (cTBS)
Other: Control (SHAM)
Control (SHAM)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of objects affordants and of objects not - affordants reminded
Time Frame: 1 week
Measure of the number of objects affordants and of objects not - affordants reminded according to if the stimulation is in PMv or control
1 week
Number of objects affordants and of objects not - affordants reminded
Time Frame: 2 weeks
Measure of the number of objects affordants and of objects not - affordants reminded according to if the stimulation is in PMv or control
2 weeks
Number of objects affordants and of objects not - affordants reminded
Time Frame: 3 weeks
Measure of the number of objects affordants and of objects not - affordants reminded according to if the stimulation is in PMv or control
3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of object reminded
Time Frame: 1 week
Measure of the number of objects affordants and of objects not - affordants reminded according to if the stimulation is excitation or control
1 week
Number of object reminded
Time Frame: 2 weeks
Measure of the number of objects affordants and of objects not - affordants reminded according to if the stimulation is excitation or control
2 weeks
Number of object reminded
Time Frame: 3 weeks
Measure of the number of objects affordants and of objects not - affordants reminded according to if the stimulation is excitation or control
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier St Anne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Paris 5 - Rene Descartes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pascale PIOLINO, University of Paris 5 - Rene Descartes
  • Study Director: Benoit CREPON, MD, CHSA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D15-P13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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