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Touching the World With a Cane: Cognitive and Neural Processes (TOOL_TOUCH)

Primary Purpose

Visual Impairment, Healthy

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Behavioral protocol

EEG protocol

fMRI protocol

About this trial

This is an interventional basic science trial for Visual Impairment focused on measuring Blind/Non-sighted, Healthy subject, fMRI, EEG

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Equipe IMPACT du CRNL, Bâtiment INSERMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

All protocols (behavioral and EEG and fMRI)

Behavioral protocol and EEG protocol

Behavioral protocol and fMRI protocol

Arm Description

If participants accepts (non-sighted participants and Healthy volunteers), they will carry out the behavioral protocol and the EEG 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.

Outcomes

Primary Outcome Measures

Perceived location

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.

Secondary Outcome Measures

Brain activity

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.

Brain activity

Measuring the brain oxygen level dependent (BOLD) signal during the realization of experimental tasks on fMRI

Full Information

NCT ID

NCT05199896

First Posted

January 4, 2022

Last Updated

August 30, 2022

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT05199896

Brief Title

Touching the World With a Cane: Cognitive and Neural Processes

Acronym

TOOL_TOUCH

Official Title

Touching the World With a (Blind) Cane: Cognitive and Neural Processes

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2022 (Actual)

Primary Completion Date

October 2026 (Anticipated)

Study Completion Date

October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The use of tools is ubiquitous in our lives and allows us to expand the sensorimotor capacities of our body. Much research has been done on the subject in sighted people over the past decades. This work has mainly focused on the motor aspect of using the tool, neglecting the sensory aspect. However, any action involving a tool carries sensory information, for example in the use of the white cane by blind people. 26% (> 200,000) of blind people in France use a white cane to get around. By sweeping the cane on the ground, they use it as a sensorimotor extension of their body to extract information from the environment in order to locate a pedestrian crossing or possible obstacles. While it is well established that the tools increase the user's motor skills, we have only just begun to clarify how they also function as sensory extensions of the user's body and how this phenomenon is potentially dependent on constant use of the tool to compensate for a missing sense, as is the case with blind people using a cane. The aim of this study is to fill this important gap in our knowledge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Visual Impairment, Healthy

Keywords

Blind/Non-sighted, Healthy subject, fMRI, EEG

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

All protocols (behavioral and EEG and fMRI)

Arm Type

Experimental

Arm Description

If participants accepts (non-sighted participants and Healthy volunteers), they will carry out the behavioral protocol and the EEG protocol and fMRI protocol.

Arm Title

Behavioral protocol and EEG protocol

Arm Type

Experimental

Arm Description

Arm Title

Behavioral protocol and fMRI protocol

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Behavioral protocol

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

EEG protocol

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

fMRI protocol

Intervention Description

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.

Primary Outcome Measure Information:

Title

Perceived location

Description

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.

Time Frame

90 minutes

Secondary Outcome Measure Information:

Title

Brain activity

Description

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.

Time Frame

6 hours

Title

Brain activity

Description

Measuring the brain oxygen level dependent (BOLD) signal during the realization of experimental tasks on fMRI

Time Frame

3 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alessandro FARNE, Dr

Phone

04 72 91 34 17

Ext

+33

alessandro.farne@inserm.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Cécile FABIO

cecile.fabio@inserm.fr

Facility Information:

Facility Name

Equipe IMPACT du CRNL, Bâtiment INSERM

City

Bron

ZIP/Postal Code

69676

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alessandro FARNE, Dr

Phone

04 72 91 34 17

Ext

+33

alessandro.farne@inserm.fr

First Name & Middle Initial & Last Name & Degree

Cécile FABIO

cecile.fabio@inserm.fr

12. IPD Sharing Statement

Plan to Share IPD

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Touching the World With a Cane: Cognitive and Neural Processes

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