HealthyNCT03201341
Multisensory Body and Space Representations (BASES-EXTINCTION)
A study testing Electrooculogram (EOG), Surface Electromyography (EMG) and Electrodermal response in people with Healthy and Blindness, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
To accurately control body movements to interact with objects, our brain needs representations of the body and the nearby space. The broader aim of this research project is to study the behavioural and physiological mechanisms involved in the constitution of these representations, to identify their neural bases, in… Read more about this study
- Who is it for?
- Ages 5 to 71 yearsHealthy volunteers can take part
- What is being tested?
- Electrooculogram (EOG), Surface Electromyography (EMG) and Electrodermal response
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,540 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2011to 11 Jul 2022
- 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 5 to 71 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female aged 5 to 71
- Subject affiliated to the general social security scheme or a similar scheme
- Subject agreeing to participate in the study with informed consent -Capable of understanding information and simple instructions related to the study
Who cannot join
- Subject under tutelage or guardianship- Subject under tutelage or guardianship
- Subject not able to give informed consent, unable to receive information about the study
- Subject not affiliated to a French or non-French social security system holder of a European health insurance card
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Saint-Genis-Laval, 69230
Gilles RODE, MD, 04 78 86 50 66 ext. +33, gilles.rode@chu-lyon.fr
About this study
Official title: Cerebral Bases of Multisensory Perception of the Body and Its Action Space
To accurately control body movements to interact with objects, our brain needs representations of the body and the nearby space. The broader aim of this research project is to study the behavioural and physiological mechanisms involved in the constitution of these representations, to identify their neural bases, in order to better understand the dysfunctions in the context of neurological or developmental disorders.
- Being tested
- Electrooculogram (EOG), Surface Electromyography (EMG), Electrodermal response, Changes in skin temperature, MRI
- Keywords
- Stroke, Multisensory, Plasticity, Body, Space, MRI
- Medical subject headings
- Blindness, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrooculogram (EOG)Other
Also called Eye-tracker
The acquisition of the surface EOG activity will be carried out by means of 3 surface electrodes, one of which, referred to as a reference, is placed on a bone zone (the glabella, above the nasion) and two others placed on The temples, coupled to an EOG amplifier.
Surface Electromyography (EMG)Other
In behavioral or transcranial stimulation protocols, surface EMG activity may be recorded for further analysis. No protocol included in this project will involve the recording of intramuscular electromyographic activity, which is invasive and involves the implantation of needle electrodes into the muscles.
Electrodermal responseOther
The electrodermal response is a useful, simple and reproducible method for recording sweat gland activity that reflects autonomic nervous activity. Recordings will be made using traditional devices, including an amplifier (Delsys or BrainAMP or equivalent) as well as disposable electrodes.
Changes in skin temperatureOther
The skin temperature will therefore be recorded during behavioral protocols using techniques for manipulating the representation of the body (perceptual illusion, prismatic deviation, etc.) using a specific measuring device.
MRIOther
Whatever the protocol, a diffusion tensor MRI (DTI) acquisition sequence as well as an image of the entire brain and high spatial resolution (T1 weight, 1x1x1 mm, nasion markers and pre-atrial points) will be acquired (Total duration: 20 minutes).
MEGOther
During the examination, the subject will have to perform tasks comparable to those described for the fMRI procedure, but with the additional possibility, offered by the MEG environment, of performing pointing or seizing of objects, provided that the Trunk and the subject's head be held in place by a suitable restraint system.
Transcranial magnetic stimulation (TMS)Other
TMS is a non-invasive technique that uses very short (~ 100μs) magnetic pulses applied to the scalp to transiently and focally disrupt or improve the functioning of neuronal populations in the underlying superficial cortical regions.
Transcranial electrical stimulation in direct current (tDCS)Other
The tDCS consists in passing a current of low intensity (generally ≤ 1mA to stimulate the cerebral cortex) between an anode and a cathode placed on the scalp, a part of this current crossing the tissues, and in particular the cortical regions situated between these two Electrodes. Generally, if the cathode is placed on the region of interest, it will be inhibited, while it will be energized if the anode is positioned thereon.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral protocol | Other | To better understand the normal functioning of the brain within the framework of the representation of the body and of the space of action. During the experiment, physiological measurements will be recorded: electrical activity at the surface of the muscles (electromyography - EMG), scalp (electroencephalography - EEG) or skin (electrodermal response). Similarly, the movements of the arm will be recorded using an infrared kinematic system requiring simply the placement of markers at strategic points such as the tip of the thumb and forefinger, the wrist, the elbow ... Movements of the eyes can also be recorded, either with the aid of an electrooculograph (EOG) or with the aid of an infrared tracking device. Electrotactile stimulations of very low intensity and painless can also be administered. Receives: Other: Electrooculogram (EOG); Other: Surface Electromyography (EMG); Other: Electrodermal response; Other: Changes in skin temperature |
| Study in fMRI | Other | To better understand the normal functioning of the brain in the representation of the body and the space of action, to identify the brain areas critical for these functions and to determine their functional roles. The examination will consist of several very short scans at the very beginning and then a scan of about ten minutes intended to take a detailed anatomical image of the brain. Then, the subject will carry out the experimental task during one or more scan (s) whose cumulative duration will not exceed 45 minutes. The task accomplished is explained in detail by the experimenter. Receives: Other: MRI |
| Study in MEG | Other | To better understand the normal functioning of the brain in the representation of the body and the space of action, to identify the critical brain areas for these functions and to determine their functional roles and to study how They interact.The complete examination includes a magnetoencephalography (MEG) experiment followed by an MRI examination. The task accomplished is explained in detail by the experimenter. Receives: Other: MRI; Other: MEG |
| Study in TMS | Other | To better understand the normal functioning of the brain in the representation of the body and the space of action, to determine the functional role of the brain areas involved in these processes. Before the Transcranial magnetic stimulation (TMS) examination, MRI of the brain will be performed.The TMS review will consist of three distinct sessions separated from one another by at least one week, depending on the protocol, and which will differ simply at the site or type of stimulation. Receives: Other: MRI; Other: Transcranial magnetic stimulation (TMS) |
| Study in tDCS | Other | To better understand the normal functioning of the brain in the representation of the body and the space of action, to determine the functional role of the cerebral areas involved in these processes. The transcranial Direct Current Stimulation (tDCS) exam will consist of three separate sessions separated from each other by at least one week and will simply differ at the stimulation site. The task accomplished is explained in detail by the experimenter. Receives: Other: Transcranial electrical stimulation in direct current (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural measure: reaction times
Mesure of reaction times.
Measured: Day 30
Behavioural measure : accuracy
Mesure of accuracy. Measurement of the accuracy of the realization of the implicit and explicit tasks according to the different approaches.
Measured: Day 30
Number of particpants with changed kinematics , via 3D optoelectronic motion tracking systems
Both latency and amplitude measures will be analysed for the presence of altered mouvement patterns in velocity, accelleration, deceleration of the arm and grip formation for the hand.
Measured: Day 30
Secondary outcomes (2)
Physiological Indices
Mesure with imaging
Measured: Day 30
Neuronal response indices
Bold, Evoked Fields, Evoked Potentials
Measured: Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start11 Jul 2011
- Primary completion11 Jun 2022 (estimated)
- Study completion11 Jul 2022 (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 Hospices Civils de LyonThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201341
- Sponsor's protocol ID
- 69HCL16_0650
- Status last verified
- Jul 2021
- First submitted
- 29 Mar 2017
- Last updated
- 20 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Bases of Multisensory Perception of the Body and Its Action Space
- ClinicalTrials.gov ID
- NCT03201341
- Acronym / sponsor ID
- 69HCL16_0650
- Keywords
- Stroke, Multisensory, Plasticity, Body, Space, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,540 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Jul 2011 (actual)
- Primary completion
- 11 Jun 2022 (estimated)
- Study completion
- 11 Jul 2022 (estimated)
- First posted
- 28 Jun 2017 (actual)
- 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.
To accurately control body movements to interact with objects, our brain needs representations of the body and the nearby space. The broader aim of this research project is to study the behavioural and physiological mechanisms involved in the constitution of these representations, to identify their neural bases, in order to better understand the dysfunctions in the context of neurological or developmental disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Behavioral protocol | Other | Other: Electrooculogram (EOG), Other: Surface Electromyography (EMG), Other: Electrodermal response, Other: Changes in skin temperatureTo better understand the normal functioning of the brain within the framework of the representation of the body and of the space of action. During the experiment, physiological measurements will be recorded: electrical activity at the surface of the muscles (electromyography - EMG), scalp (electroencephalography - EEG) or skin (electrodermal response). Similarly, the movements of the arm will be recorded using an infrared kinematic system requiring simply the placement of markers at strategic points such as the tip of the thumb and forefinger, the wrist, the elbow ... Movements of the eyes can also be recorded, either with the aid of an electrooculograph (EOG) or with the aid of an infrared tracking device. Electrotactile stimulations of very low intensity and painless can also be administered. |
| Study in fMRI | Other | Other: MRITo better understand the normal functioning of the brain in the representation of the body and the space of action, to identify the brain areas critical for these functions and to determine their functional roles. The examination will consist of several very short scans at the very beginning and then a scan of about ten minutes intended to take a detailed anatomical image of the brain. Then, the subject will carry out the experimental task during one or more scan (s) whose cumulative duration will not exceed 45 minutes. The task accomplished is explained in detail by the experimenter. |
| Study in MEG | Other | Other: MRI, Other: MEGTo better understand the normal functioning of the brain in the representation of the body and the space of action, to identify the critical brain areas for these functions and to determine their functional roles and to study how They interact.The complete examination includes a magnetoencephalography (MEG) experiment followed by an MRI examination. The task accomplished is explained in detail by the experimenter. |
| Study in TMS | Other | Other: MRI, Other: Transcranial magnetic stimulation (TMS)To better understand the normal functioning of the brain in the representation of the body and the space of action, to determine the functional role of the brain areas involved in these processes. Before the Transcranial magnetic stimulation (TMS) examination, MRI of the brain will be performed.The TMS review will consist of three distinct sessions separated from one another by at least one week, depending on the protocol, and which will differ simply at the site or type of stimulation. |
| Study in tDCS | Other | Other: Transcranial electrical stimulation in direct current (tDCS)To better understand the normal functioning of the brain in the representation of the body and the space of action, to determine the functional role of the cerebral areas involved in these processes. The transcranial Direct Current Stimulation (tDCS) exam will consist of three separate sessions separated from each other by at least one week and will simply differ at the stimulation site. The task accomplished is explained in detail by the experimenter. |
Who may qualify
- Ages
- 5 to 71 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged 5 to 71
- Subject affiliated to the general social security scheme or a similar scheme
- Subject agreeing to participate in the study with informed consent -Capable of understanding information and simple instructions related to the study
Key exclusion criteria (3 listed)
- Subject under tutelage or guardianship- Subject under tutelage or guardianship
- Subject not able to give informed consent, unable to receive information about the study
- Subject not affiliated to a French or non-French social security system holder of a European health insurance card
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 |
|---|---|---|
| Electrooculogram (EOG)Also: Eye-trackerThe acquisition of the surface EOG activity will be carried out by means of 3 surface electrodes, one of which, referred to as a reference, is placed on a bone zone (the glabella, above the nasion) and two others placed on The temples, coupled to an EOG amplifier. | Other | Behavioral protocol |
| Surface Electromyography (EMG)In behavioral or transcranial stimulation protocols, surface EMG activity may be recorded for further analysis. No protocol included in this project will involve the recording of intramuscular electromyographic activity, which is invasive and involves the implantation of needle electrodes into the muscles. | Other | Behavioral protocol |
| Electrodermal responseThe electrodermal response is a useful, simple and reproducible method for recording sweat gland activity that reflects autonomic nervous activity. Recordings will be made using traditional devices, including an amplifier (Delsys or BrainAMP or equivalent) as well as disposable electrodes. | Other | Behavioral protocol |
| Changes in skin temperatureThe skin temperature will therefore be recorded during behavioral protocols using techniques for manipulating the representation of the body (perceptual illusion, prismatic deviation, etc.) using a specific measuring device. | Other | Behavioral protocol |
| MRIWhatever the protocol, a diffusion tensor MRI (DTI) acquisition sequence as well as an image of the entire brain and high spatial resolution (T1 weight, 1x1x1 mm, nasion markers and pre-atrial points) will be acquired (Total duration: 20 minutes). | Other | Study in MEG, Study in TMS, Study in fMRI |
| MEGDuring the examination, the subject will have to perform tasks comparable to those described for the fMRI procedure, but with the additional possibility, offered by the MEG environment, of performing pointing or seizing of objects, provided that the Trunk and the subject's head be held in place by a suitable restraint system. | Other | Study in MEG |
| Transcranial magnetic stimulation (TMS)TMS is a non-invasive technique that uses very short (~ 100μs) magnetic pulses applied to the scalp to transiently and focally disrupt or improve the functioning of neuronal populations in the underlying superficial cortical regions. | Other | Study in TMS |
| Transcranial electrical stimulation in direct current (tDCS)The tDCS consists in passing a current of low intensity (generally ≤ 1mA to stimulate the cerebral cortex) between an anode and a cathode placed on the scalp, a part of this current crossing the tissues, and in particular the cortical regions situated between these two Electrodes. Generally, if the cathode is placed on the region of interest, it will be inhibited, while it will be energized if the anode is positioned thereon. | Other | Study in tDCS |
Primary outcome
Behavioural measure: reaction times
Time frame: Day 30
Mesure of reaction times.
Behavioural measure : accuracy
Time frame: Day 30
Mesure of accuracy. Measurement of the accuracy of the realization of the implicit and explicit tasks according to the different approaches.
Number of particpants with changed kinematics , via 3D optoelectronic motion tracking systems
Time frame: Day 30
Both latency and amplitude measures will be analysed for the presence of altered mouvement patterns in velocity, accelleration, deceleration of the arm and grip formation for the hand.
2 secondary outcomes
Physiological Indices
Time frame: Day 30
Neuronal response indices
Time frame: Day 120
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrooculogram (EOG), Surface Electromyography (EMG) and Electrodermal response in people with Healthy and Blindness, run by Hospices Civils de Lyon 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 3 inclusion and 3 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 20 Jul 2021. 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 Gilles RODE, MD (04 78 86 50 66 ext. +33, gilles.rode@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioural measure: reaction times (time frame: Day 30). 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 20 Jul 2021.