- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04288505
Evaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Brain Damage -TANGO (TANGO)
July 25, 2025 updated by: University Hospital, Angers
Evaluate the diagnostic performance of a virtual reality application to detect the presence of cognitive impairment of the non-dominant hemisphere in patients with brain damage
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
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
-
-
-
Angers, France, 49000
- University Hospital
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Indication for brain lesion located in the right hemisphere surgery
- Major patient
- Karnofsky ≥ 70
Exclusion Criteria:
- Person with aphasia
- Person with visual problems
- Person with a contraindication to MRI
- Person unable to carry out the tests planned in the study
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: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: single arm
|
application on virtual reality headset
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Performance of the virtual reality application compared to classic cognitive tests batery for the detection of cognitive deficit
Time Frame: from surgery to 3 months after surgery
|
from surgery to 3 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Performance of the virtual reality application compared with conventional cognitive tests used to detect visual-spatial attention disorders
Time Frame: from surgery to 3 months after surgery
|
from surgery to 3 months after surgery
|
|
Performance of the virtual reality application compared with conventional cognitive tests used to detect facial emotion recognition disorders
Time Frame: from surgery to 3 months after surgery
|
from surgery to 3 months after surgery
|
|
Performance of the virtual reality application compared with conventional cognitive tests, used to detect spatial attention disorders or the presence of facial emotion recognition disorders depending respectively on the location or type of facial emotion
Time Frame: from surgery to 3 months after surgery
|
from surgery to 3 months after surgery
|
|
Study the reproducibility of the virtual reality application for detecting the presence of cognitive function disorders
Time Frame: from surgery to 3 months after surgery
|
from surgery to 3 months after surgery
|
|
Study the correlation between visuo-spatial and facial emotion recognition deficits and possible tractographic changes
Time Frame: from surgery to 3 months after surgery
|
from surgery to 3 months after surgery
|
|
Study the association between the presence of cognitive function deficits and the presence of behavioral disorders or health-related quality of life
Time Frame: from surgery to 3 months after surgery
|
from surgery to 3 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
May 15, 2020
Primary Completion (Actual)
February 4, 2025
Study Completion (Actual)
May 5, 2025
Study Registration Dates
First Submitted
February 14, 2020
First Submitted That Met QC Criteria
February 25, 2020
First Posted (Actual)
February 28, 2020
Study Record Updates
Last Update Posted (Actual)
July 30, 2025
Last Update Submitted That Met QC Criteria
July 25, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-A00074-35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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