- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02201927
Stimulation Galvanique Vestibulaire (GVS)
February 2, 2015 updated by: Centre d'Investigation Clinique et Technologique 805
Galvanic Vestibular Stimulation : Role in the Improvement of Egocentric Frame in Patient With Right Parietal Lobe Lesions
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Garches, France, 92380
- Hopital Raymond Poincare Mpr
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patient with right parietal lobe lesion
Patient with right parietal lobe lesion
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Other Names:
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Experimental: patient stroke
patient with cerebral vascular accident
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Other Names:
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Experimental: healthy volunteers
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
deviation from target score
Time Frame: 30 min
|
difference in degree between the actual and target score
|
30 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
deviation from target "straight ahead"
Time Frame: 30min
|
difference in degree between the actual straight ahead and target score
|
30min
|
deviation rightward line bisection
Time Frame: 30min
|
percentage difference between actual and target score on test "deviation right line bisection"
|
30min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ruet Alexis, PHD, Hôpital Raymond Poincaré
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
July 22, 2014
First Submitted That Met QC Criteria
July 24, 2014
First Posted (Estimate)
July 28, 2014
Study Record Updates
Last Update Posted (Estimate)
February 3, 2015
Last Update Submitted That Met QC Criteria
February 2, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-A01243-42/1
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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