HealthySIMULANG-TMSNCT02956304
" Effect of Affordance of Objects on the Memory: Study in Transcranial Magnetic Stimulation "
A study testing PMv stimulation (iTBS) and PMv inhibition (cTBS) in people with Healthy, run by Centre Hospitalier St Anne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PMv stimulation (iTBS) and PMv inhibition (cTBS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2017to Nov 2018
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre de Recherche Clinique (CRC) - CHSA
Paris, 75014
Macarena CUENCA, m.cuenca@ch-sainte-anne.fr
Cecile Bergot, 00 33 1 45 65 84 90, c.bergot@ch-sainte-anne.fr
About this study
Official title: " 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- PMv stimulation (iTBS), PMv inhibition (cTBS), Control (SHAM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMv stimulation (iTBS)Other
PMv stimulation (iTBS)
PMv inhibition (cTBS)Other
PMv inhibition (cTBS)
Control (SHAM)Other
Control (SHAM)
| Study group | Role | What they receive |
|---|---|---|
| Group iTBS-cTBS-SHAM | Other | PMv stimulation (iTBS) at session 2, PMv inhibition (cTBS) at session 3, and control (SHAM) at session 4 Receives: Other: PMv stimulation (iTBS); Other: PMv inhibition (cTBS); Other: Control (SHAM) |
| Group iTBS-SHAM-cTBS | Other | PMv stimulation (iTBS) at session 2, control (SHAM) at session 3, and PMv inhibition (cTBS) at session 4 Receives: Other: PMv stimulation (iTBS); Other: PMv inhibition (cTBS); Other: Control (SHAM) |
| Group cTBS-iTBS-SHAM | Other | PMv inhibition (cTBS) at session 2, PMv stimulation (iTBS) at session 3, and control (SHAM) at session 4 Receives: Other: PMv stimulation (iTBS); Other: PMv inhibition (cTBS); Other: Control (SHAM) |
| Group cTBS-SHAM-iTBS | Other | PMv inhibition (cTBS) at session 2, control (SHAM) at session 3, and PMv stimulation (iTBS) at session 4 Receives: Other: PMv stimulation (iTBS); Other: PMv inhibition (cTBS); Other: Control (SHAM) |
| Group SHAM-iTBS-cTBS | Other | control (SHAM) at session 2, PMv stimulation (iTBS) at session 3, and PMv inhibition (cTBS) at session 4 Receives: Other: PMv stimulation (iTBS); Other: PMv inhibition (cTBS); Other: Control (SHAM) |
| Group SHAM-cTBS-iTBS | Other | control (SHAM) at session 2, PMv inhibition (cTBS) at session 3, and PMv stimulation (iTBS) at session 4 Receives: Other: PMv stimulation (iTBS); Other: PMv inhibition (cTBS); Other: Control (SHAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 weeks
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start3 Apr 2017
- Primary completionJul 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- University of Paris 5 - Rene Descartes
- Responsible party
- Sponsor
- Investigators
- Pascale PIOLINO, Study director, University of Paris 5 - Rene DescartesBenoit CREPON, MD, Study director, CHSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956304
- Sponsor's protocol ID
- D15-P13
- Acronym
- SIMULANG-TMS
- Status last verified
- Apr 2017
- First submitted
- 20 Jul 2016
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " Effect of Affordance of Objects on the Memory: Study in Transcranial Magnetic Stimulation " (SIMULANG-TMS)
- ClinicalTrials.gov ID
- NCT02956304
- Acronym / sponsor ID
- SIMULANG-TMS / D15-P13
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- University of Paris 5 - Rene Descartes
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 7 Nov 2016 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group iTBS-cTBS-SHAM | Other | Other: PMv stimulation (iTBS), Other: PMv inhibition (cTBS), Other: Control (SHAM)PMv stimulation (iTBS) at session 2, PMv inhibition (cTBS) at session 3, and control (SHAM) at session 4 |
| Group iTBS-SHAM-cTBS | Other | Other: PMv stimulation (iTBS), Other: PMv inhibition (cTBS), Other: Control (SHAM)PMv stimulation (iTBS) at session 2, control (SHAM) at session 3, and PMv inhibition (cTBS) at session 4 |
| Group cTBS-iTBS-SHAM | Other | Other: PMv stimulation (iTBS), Other: PMv inhibition (cTBS), Other: Control (SHAM)PMv inhibition (cTBS) at session 2, PMv stimulation (iTBS) at session 3, and control (SHAM) at session 4 |
| Group cTBS-SHAM-iTBS | Other | Other: PMv stimulation (iTBS), Other: PMv inhibition (cTBS), Other: Control (SHAM)PMv inhibition (cTBS) at session 2, control (SHAM) at session 3, and PMv stimulation (iTBS) at session 4 |
| Group SHAM-iTBS-cTBS | Other | Other: PMv stimulation (iTBS), Other: PMv inhibition (cTBS), Other: Control (SHAM)control (SHAM) at session 2, PMv stimulation (iTBS) at session 3, and PMv inhibition (cTBS) at session 4 |
| Group SHAM-cTBS-iTBS | Other | Other: PMv stimulation (iTBS), Other: PMv inhibition (cTBS), Other: Control (SHAM)control (SHAM) at session 2, PMv inhibition (cTBS) at session 3, and PMv stimulation (iTBS) at session 4 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| PMv stimulation (iTBS)PMv stimulation (iTBS) | Other | Group SHAM-cTBS-iTBS, Group SHAM-iTBS-cTBS, Group cTBS-SHAM-iTBS, Group cTBS-iTBS-SHAM, Group iTBS-SHAM-cTBS, Group iTBS-cTBS-SHAM |
| PMv inhibition (cTBS)PMv inhibition (cTBS) | Other | Group SHAM-cTBS-iTBS, Group SHAM-iTBS-cTBS, Group cTBS-SHAM-iTBS, Group cTBS-iTBS-SHAM, Group iTBS-SHAM-cTBS, Group iTBS-cTBS-SHAM |
| Control (SHAM)Control (SHAM) | Other | Group SHAM-cTBS-iTBS, Group SHAM-iTBS-cTBS, Group cTBS-SHAM-iTBS, Group cTBS-iTBS-SHAM, Group iTBS-SHAM-cTBS, Group iTBS-cTBS-SHAM |
Primary outcome
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
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
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 secondary outcomes
Number of object reminded
Time frame: 1 week
Number of object reminded
Time frame: 2 weeks
Number of object reminded
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Pascale PIOLINO study director
University of Paris 5 - Rene Descartes
Benoit CREPON, MD study director
CHSA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PMv stimulation (iTBS) and PMv inhibition (cTBS) in people with Healthy, run by Centre Hospitalier St Anne 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 6 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: status not confirmed, as of the sponsor's last update on 28 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benoit CREPON, MD (00 33 1 45 65 87 70, b.crepon@ch-sainte-anne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of objects affordants and of objects not - affordants reminded (time frame: 1 week). The study lists 3 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 28 Apr 2017.