Sensori-motor and Perceptual Functions of the PPC. (PPCfonctions)
Primary Purpose
Healthy Volunteers, Optic Ataxia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
point targets
tactile stimulation
visual images
Sponsored by
About this trial
This is an interventional basic science trial for Healthy Volunteers focused on measuring optic ataxia, posterior parietal cortex functions, multisensory integration
Eligibility Criteria
Inclusion Criteria:
All patients and healthy subjects:
- male and female, age from 18 to 75 years included
- normal vision or corrected vision
- covered by social security
- signed written informed consent
Patients:
- neurological injury in posterior parietal cortex supported by a cerebral MRI
- present optic ataxia symptoms Healthy subjects
- no known neurological injury
Exclusion Criteria:
- unable to comply with the tasks (neurological, psychiatric, sensory or motor troubles)
Sites / Locations
- U1028 INSERM - CNRS UMR 5292 Equipe ImpActRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Experience 1
Experience 2
Experience 3
Experience 4
Experience 5
Experience 6
Arm Description
Outcomes
Primary Outcome Measures
response error - number of pointing error
response error -measure of reaction times
response error - percentage of right responses
Secondary Outcome Measures
Full Information
NCT ID
NCT03286686
First Posted
September 14, 2017
Last Updated
October 17, 2023
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT03286686
Brief Title
Sensori-motor and Perceptual Functions of the PPC.
Acronym
PPCfonctions
Official Title
Sensori-motor and Perceptual Functions of the Posterior Parietal Cortex (PPC) in Patients With Optic Ataxia (AO) and Healthy Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
February 22, 2029 (Anticipated)
Study Completion Date
February 22, 2029 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To produce hand's movement directed towards a target, the investigator must combine several sensory information, such as vision or proprioception. The posterior parietal cortex (PPC) is a region of the cortex involved in this multisensory integration. A lesion of the PPC cause a visuo-motor trouble called optic ataxia but these patients also have perceptual troubles.
The aim of the study is to understand the different functions of the PPC and especially how the processes of spatial coding of the sensory information influences perception and motor planning.
In this study, the investigator want to explore the sensory motor and the perceptual performance of patients with optic ataxia compared with healthy subjects, using 6 behavioral tests.
Objectify the consequences of PPC impairment (visual-motor and perceptual consequences) on patients' quality of life and autonomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Optic Ataxia
Keywords
optic ataxia, posterior parietal cortex functions, multisensory integration
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experience 1
Arm Type
Experimental
Arm Title
Experience 2
Arm Type
Experimental
Arm Title
Experience 3
Arm Type
Experimental
Arm Title
Experience 4
Arm Type
Experimental
Arm Title
Experience 5
Arm Type
Experimental
Arm Title
Experience 6
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
point targets
Intervention Description
In the experiences 1 and 2, the participant needs to point different visual targets (LED) in the dark.
Intervention Type
Behavioral
Intervention Name(s)
tactile stimulation
Intervention Description
In the experience 3, a tactile stimulation is applied to the middle finger of the 2 hands. The participant needs to indicate into a microphone when he feels the stimulation.
Intervention Type
Behavioral
Intervention Name(s)
visual images
Intervention Description
Target dots or visual images are presented on a computer screen. The participant is required to point to the targets or to react as soon as possible by pressing a response button when they are detected.
Primary Outcome Measure Information:
Title
response error - number of pointing error
Time Frame
Day 0 after each stimulation
Title
response error -measure of reaction times
Time Frame
Day 0 after each stimulation
Title
response error - percentage of right responses
Time Frame
Day 0 after each stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients and healthy subjects:
male and female, age from 18 to 75 years included
normal vision or corrected vision
covered by social security
signed written informed consent
Patients:
neurological injury in posterior parietal cortex supported by a cerebral MRI
present optic ataxia symptoms Healthy subjects
no known neurological injury
Exclusion Criteria:
- unable to comply with the tasks (neurological, psychiatric, sensory or motor troubles)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laure PISELLA, PhD
Phone
4 72 91 34 05
Ext
+33
Email
laure.pisella@inserm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laure PISELLA, PhD
Organizational Affiliation
INSERM U1028 - Impact - CRNL
Official's Role
Principal Investigator
Facility Information:
Facility Name
U1028 INSERM - CNRS UMR 5292 Equipe ImpAct
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure Pisella, PhD
Phone
4 72 91 34 05
Ext
+33
Email
laure.pisella@inserm.fr
First Name & Middle Initial & Last Name & Degree
Laure Pisella, PhD
First Name & Middle Initial & Last Name & Degree
Sophie JACQUIN-COURTOIS, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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