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Evaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Glioma -TANGO (TANGO)

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ClinicalTrials.gov Identifier: NCT04288505
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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Brief Summary:
Evaluate the diagnostic performance of a virtual reality application to detect the presence of cognitive impairment of the non-dominant hemisphere in patients with glioma

Condition or disease Intervention/treatment Phase
Brain Tumor Virtual Reality Diagnostic Test: VIRTUAL REALITY application Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Glioma -TANGO
Actual Study Start Date : May 28, 2020
Estimated Primary Completion Date : February 20, 2024
Estimated Study Completion Date : March 1, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: single arm Diagnostic Test: VIRTUAL REALITY application
application on virtual reality headset


Outcome Measures
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Primary Outcome Measures :
  1. PERFORMANCE OF the VR APPLICATION compared to classic cognitive tests batery for the detection of cognitive deficit [ Time Frame: from surgery to 3 months after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indication for glioma surgery
  • Karnofsky > 70

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04288505


Contacts
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Contact: Jean Michel Lemee +33241356786 JMLemee@chu-angers.fr

Locations
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France
University hospital Recruiting
Angers, France, 49000
Contact: Jean Michel LEMEE    +33241356786    JMLemee@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
More Information
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04288505    
Other Study ID Numbers: 2020-A00074-35
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
 Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases