Back to resultsStimulation Galvanique Vestibulaire (GVS)
Primary Purpose
Hypertensive Hemorrhage of Right Parietal Lobe
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
galvanic vestibular stimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Hypertensive Hemorrhage of Right Parietal Lobe focused on measuring galvanic vestibular stimulation, right parietal lobe lesion, egocentric space
Eligibility Criteria
Inclusion Criteria:
- patient with right posterieur parietal lobe lesion
- patient with cerebral vascular stroke
- healthy volonteers Age greater than or equal to 18 written informed consent
Exclusion Criteria:
- patient's refusal to participate to the study
- inability to cooperate
- cognitive trouble
- epilepsy
Sites / Locations
- Hopital Raymond Poincare Mpr
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
patient with right parietal lobe lesion
patient stroke
healthy volunteers
Arm Description
Patient with right parietal lobe lesion
patient with cerebral vascular accident
healthy volunteers
Outcomes
Primary Outcome Measures
deviation from target score
difference in degree between the actual and target score
Secondary Outcome Measures
deviation from target "straight ahead"
difference in degree between the actual straight ahead and target score
deviation rightward line bisection
percentage difference between actual and target score on test "deviation right line bisection"
Full Information
NCT ID
NCT02201927
First Posted
July 22, 2014
Last Updated
February 2, 2015
Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
University of Versailles
1. Study Identification
Unique Protocol Identification Number
NCT02201927
Brief Title
Stimulation Galvanique Vestibulaire
Acronym
GVS
Official Title
Galvanic Vestibular Stimulation : Role in the Improvement of Egocentric Frame in Patient With Right Parietal Lobe Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
lack of performance
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
University of Versailles
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Right posterior parietal cortex is involved in spatial cognition. Blindfolded patients suffering right posterior parietal lesions fail to update their own position after a body rotation. Right cathodal galvanic vestibular stimulation activates right posterior parietal cortex and reduces symptoms of spatial neglect, another disability frequently encountered after right posterior parietal lesion. The aims of this study are to confirm posterior parietal involvement in automatic updating of body-centered spatial relationships and to evaluate therapeutic effects of galvanic vestibular stimulation. Performances of three groups of adults are compared before and during galvanic vestibular stimulation on a pointing task: a healthy control group, a brain-injured control group with stroke lesions sparing right posterior parietal cortex and a group of stroke patients with right posterior parietal lesions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Hemorrhage of Right Parietal Lobe
Keywords
galvanic vestibular stimulation, right parietal lobe lesion, egocentric space
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient with right parietal lobe lesion
Arm Type
Experimental
Arm Description
Patient with right parietal lobe lesion
Arm Title
patient stroke
Arm Type
Experimental
Arm Description
patient with cerebral vascular accident
Arm Title
healthy volunteers
Arm Type
Experimental
Arm Description
healthy volunteers
Intervention Type
Device
Intervention Name(s)
galvanic vestibular stimulation
Other Intervention Name(s)
deviation from target score with and without galvanic vestibular stimulation
Primary Outcome Measure Information:
Title
deviation from target score
Description
difference in degree between the actual and target score
Time Frame
30 min
Secondary Outcome Measure Information:
Title
deviation from target "straight ahead"
Description
difference in degree between the actual straight ahead and target score
Time Frame
30min
Title
deviation rightward line bisection
Description
percentage difference between actual and target score on test "deviation right line bisection"
Time Frame
30min
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:
patient with right posterieur parietal lobe lesion
patient with cerebral vascular stroke
healthy volonteers Age greater than or equal to 18 written informed consent
Exclusion Criteria:
patient's refusal to participate to the study
inability to cooperate
cognitive trouble
epilepsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruet Alexis, PHD
Organizational Affiliation
HOPITAL RAYMOND POINCARE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Raymond Poincare Mpr
City
Garches
ZIP/Postal Code
92380
Country
France
12. IPD Sharing Statement
Learn more about this trial
Stimulation Galvanique Vestibulaire
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