- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05199896
Touching the World With a Cane: Cognitive and Neural Processes (TOOL_TOUCH)
Touching the World With a (Blind) Cane: Cognitive and Neural Processes
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alessandro FARNE, Dr
- Phone Number: +33 04 72 91 34 17
- Email: alessandro.farne@inserm.fr
Study Contact Backup
- Name: Cécile FABIO
- Email: cecile.fabio@inserm.fr
Study Locations
-
-
-
Bron, France, 69676
- Recruiting
- Equipe IMPACT du CRNL, Bâtiment INSERM
-
Contact:
- Alessandro FARNE, Dr
- Phone Number: +33 04 72 91 34 17
- Email: alessandro.farne@inserm.fr
-
Contact:
- Cécile FABIO
- Email: cecile.fabio@inserm.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Man or woman, aged 18 to 60 years old
- Give an informed consent by signature
- Be part of the national health security system (registered to the Securité Sociale)
- do not confuse his right and his left
Specific of the non-sighted participants:
- Loss of vision happened at birth or 3-to 5 years later in life
- Must have a visual acuity inferior or equal to 4/10
- Be with a close relation for read information letter and sign the consent form if needed
Exclusion Criteria:
- A person presenting an history of neurological, psychiatric or linguistic problems cannot be admitted
- Assumption of psychotropic drugs
- Pregnancy or breast-feeding woman
- A person under legal tutoring
- A person under care in other medical structure for reasons different from those of this research
- A person under administrative or judiciary contention
A person who is not eligible to a MRI-exam according to the following criteria cannot be admitted to the experiments including MR acquisitions :
- Have a neurological, cardiac (battery) or defibrillator pacemaker
- Have a cardiac prosthesis (valve, stent...) or vascular prosthesis
- Have intracranial clips or clamps
- Carry a bypass of the cerebrospinal fluid
- Having metallic splinters in the eyes
- Wear metal prostheses (teeth, knees)
- Wear an infusion pump or system
- Be claustrophobic or have respiratory problems
- Have metal tattoos close to the head
- Have permanent make-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: All protocols (behavioral and EEG and fMRI)
If participants accepts (non-sighted participants and Healthy volunteers), they will carry out the behavioral protocol and the EEG protocol and fMRI protocol.
|
A touch sensitive computer screen either displaying a downscaled (45cm long) image of the rod (for the sighted), or supporting a same sized wooden rod (for the blind), will be placed on the table in front of the participant to record their localization performance.
They will be instructed to use their left index fingertip to indicate on the image of the screen (for sighted) or on the wooden rod (for the blind) the position where they have felt the touch provided to the 90 cm long they held in their right dominant hand.
Participants will wear a headset playing white noise to prevent any auditory localization cues when the long rod will be touched.
The rod will be touched by a computer controlled solenoid.
Thus, participants will respond with a hand gesture on the image or rod and will be asked to validate the position by pressing a foot-pedal with their left foot.
The EEG protocol will be similar as the behavioral one described above, with the distinction of taking place in two separate sessions: one where the rod are touched, and one where their hand is touched. The participant will hold a rod in each hand and he will have to indicate on which rod he felt the touch. Additionally electrophysiological responses will be continuously recorded using a 65 channel ActiCap system (Brain Products). The same behavioral task and procedures of the behavioral protocol described above will be applied, adapted to take into account the constraints posed by the magnetic environment of the MR scanner. The participant will be placed on the scanner bed and provided with earphones that will both protect against the noise of the machine (80dB) and ensure a continuous communication with the participant. During the fMRI sessions, the participant will solve the same rod localization behavioral task while we will record brain activations by measuring the brain oxygen level dependent signal via Echo Planar Imaging sequences. We will use an MRI compatible tactile stimulator to touch the hand-held rod and participants location judgement will be recorded by using an MRI-compatible tablet, positioned on their abdomen, where the participant will have to indicate the judged position. |
EXPERIMENTAL: Behavioral protocol and EEG protocol
Participants who agree to participate in only one of the experiments (EEG or MRI) will be randomly (by a randomization list) assigned to either the EEG or fMRI type of study in each subgroup. All participants (non-sighted participants and Healthy volunteers) will do the behavioral session and at least one EEG or MRI session depending on randomization. |
A touch sensitive computer screen either displaying a downscaled (45cm long) image of the rod (for the sighted), or supporting a same sized wooden rod (for the blind), will be placed on the table in front of the participant to record their localization performance.
They will be instructed to use their left index fingertip to indicate on the image of the screen (for sighted) or on the wooden rod (for the blind) the position where they have felt the touch provided to the 90 cm long they held in their right dominant hand.
Participants will wear a headset playing white noise to prevent any auditory localization cues when the long rod will be touched.
The rod will be touched by a computer controlled solenoid.
Thus, participants will respond with a hand gesture on the image or rod and will be asked to validate the position by pressing a foot-pedal with their left foot.
The EEG protocol will be similar as the behavioral one described above, with the distinction of taking place in two separate sessions: one where the rod are touched, and one where their hand is touched. The participant will hold a rod in each hand and he will have to indicate on which rod he felt the touch. Additionally electrophysiological responses will be continuously recorded using a 65 channel ActiCap system (Brain Products). |
EXPERIMENTAL: Behavioral protocol and fMRI protocol
Participants who agree to participate in only one of the experiments (EEG or MRI) will be randomly (by a randomization list) assigned to either the EEG or fMRI type of study in each subgroup. All participants (non-sighted participants and Healthy volunteers) will do the behavioral session and at least one EEG or MRI session depending on randomization. |
A touch sensitive computer screen either displaying a downscaled (45cm long) image of the rod (for the sighted), or supporting a same sized wooden rod (for the blind), will be placed on the table in front of the participant to record their localization performance.
They will be instructed to use their left index fingertip to indicate on the image of the screen (for sighted) or on the wooden rod (for the blind) the position where they have felt the touch provided to the 90 cm long they held in their right dominant hand.
Participants will wear a headset playing white noise to prevent any auditory localization cues when the long rod will be touched.
The rod will be touched by a computer controlled solenoid.
Thus, participants will respond with a hand gesture on the image or rod and will be asked to validate the position by pressing a foot-pedal with their left foot.
The same behavioral task and procedures of the behavioral protocol described above will be applied, adapted to take into account the constraints posed by the magnetic environment of the MR scanner. The participant will be placed on the scanner bed and provided with earphones that will both protect against the noise of the machine (80dB) and ensure a continuous communication with the participant. During the fMRI sessions, the participant will solve the same rod localization behavioral task while we will record brain activations by measuring the brain oxygen level dependent signal via Echo Planar Imaging sequences. We will use an MRI compatible tactile stimulator to touch the hand-held rod and participants location judgement will be recorded by using an MRI-compatible tablet, positioned on their abdomen, where the participant will have to indicate the judged position. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived location
Time Frame: 90 minutes
|
Tactile stimulus will be applied on a tool (a rod). Subject should determine the exact spatial location of the stimulus. This will be measure at each stimulation. |
90 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain activity
Time Frame: 6 hours
|
Brain oscillatory activity and the somatosensory evoked potentials during the realization of experimental tasks on EEG. Two sessions of about 3 hours are necessary for the EEG acquisition. |
6 hours
|
Brain activity
Time Frame: 3 hours
|
Measuring the brain oxygen level dependent (BOLD) signal during the realization of experimental tasks on fMRI
|
3 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL21_0882
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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