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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02956304
Recruitment Status : Unknown
Verified April 2017 by Centre Hospitalier St Anne.
Recruitment status was:  Recruiting
First Posted : November 6, 2016
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
University of Paris 5 - Rene Descartes
Information provided by (Responsible Party):
Centre Hospitalier St Anne

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Other: PMv stimulation (iTBS) Other: PMv inhibition (cTBS) Other: Control (SHAM) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: " Effect of Affordance of Objects on the Memory: Study in Transcranial Magnetic Stimulation " (SIMULANG-TMS)
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
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)

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)

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)

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)

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)

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)




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956304


Contacts
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Contact: Benoit CREPON, MD 00 33 1 45 65 87 70 b.crepon@ch-sainte-anne.fr
Contact: Marie GODARD 00 33 1 45 65 77 28 marie.godard@aphp.fr

Locations
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France
Centre de Recherche Clinique (CRC) - CHSA Recruiting
Paris, France, 75014
Contact: Macarena CUENCA       m.cuenca@ch-sainte-anne.fr   
Contact: Cecile Bergot    00 33 1 45 65 84 90    c.bergot@ch-sainte-anne.fr   
Principal Investigator: Macarena CUENCA         
Sponsors and Collaborators
Centre Hospitalier St Anne
University of Paris 5 - Rene Descartes
Investigators
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Study Director: Pascale PIOLINO University of Paris 5 - Rene Descartes
Study Director: Benoit CREPON, MD CHSA

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Responsible Party: Centre Hospitalier St Anne
ClinicalTrials.gov Identifier: NCT02956304    
Other Study ID Numbers: D15-P13
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No