Back to resultsEvaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Glioma -TANGO (TANGO)
Primary Purpose
Brain Tumor, Virtual Reality
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
VIRTUAL REALITY application
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Tumor
Eligibility Criteria
Inclusion Criteria:
- Indication for glioma surgery
- Karnofsky > 70
Exclusion Criteria:
-
Sites / Locations
- University hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
Outcomes
Primary Outcome Measures
PERFORMANCE OF the VR APPLICATION compared to classic cognitive tests batery for the detection of cognitive deficit
Secondary Outcome Measures
Full Information
NCT ID
NCT04288505
First Posted
February 14, 2020
Last Updated
June 2, 2020
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT04288505
Brief Title
Evaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Glioma -TANGO
Acronym
TANGO
Official Title
Evaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Glioma -TANGO
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2020 (Actual)
Primary Completion Date
February 20, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Virtual Reality
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
VIRTUAL REALITY application
Intervention Description
application on virtual reality headset
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Indication for glioma surgery
Karnofsky > 70
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Michel Lemee
Phone
+33241356786
Email
JMLemee@chu-angers.fr
Facility Information:
Facility Name
University hospital
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Michel LEMEE
Phone
+33241356786
Email
JMLemee@chu-angers.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Glioma -TANGO
We'll reach out to this number within 24 hrs