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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02201927
Other study ID # 2013-A01243-42/1
Secondary ID
Status Terminated
Phase N/A
First received July 22, 2014
Last updated February 2, 2015
Start date April 2014
Est. completion date October 2014

Study information

Verified date February 2015
Source Centre d'Investigation Clinique et Technologique 805
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms

  • Hypertensive Hemorrhage of Right Parietal Lobe

Intervention

Device:
galvanic vestibular stimulation


Locations

Country Name City State
France Hopital Raymond Poincare Mpr Garches

Sponsors (2)

Lead Sponsor Collaborator
Centre d'Investigation Clinique et Technologique 805 University of Versailles

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary deviation from target score difference in degree between the actual and target score 30 min No
Secondary deviation from target "straight ahead" difference in degree between the actual straight ahead and target score 30min No
Secondary deviation rightward line bisection percentage difference between actual and target score on test "deviation right line bisection" 30min No