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

" 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: Unknown
• Conditions: Healthy
• Intervention / Treatment: Other: PMv stimulation (iTBS); Other: PMv inhibition (cTBS); Other: Control (SHAM)

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benoit CREPON, MD; Phone Number: 00 33 1 45 65 87 70; Email: b.crepon@ch-sainte-anne.fr
• Study Contact Backup: Name: Marie GODARD; Phone Number: 00 33 1 45 65 77 28; Email: marie.godard@aphp.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Centre de Recherche Clinique (CRC) - CHSA
    • Contact: Macarena CUENCA; Email: m.cuenca@ch-sainte-anne.fr
    • Contact: Cecile Bergot; Phone Number: 00 33 1 45 65 84 90; Email: c.bergot@ch-sainte-anne.fr
    • Principal Investigator: Macarena CUENCA

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Number of objects affordants and of objects not - affordants reminded	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	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	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

Outcome Measure	Measure Description	Time Frame
Number of object reminded	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	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	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

• Sponsor: Centre Hospitalier St Anne
• Collaborators: University of Paris 5 - Rene Descartes
• Investigators: Study Director: Pascale PIOLINO, University of Paris 5 - Rene Descartes; Study Director: Benoit CREPON, MD, CHSA

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID 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