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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05373394
Other study ID # DR220033
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 19, 2022
Est. completion date June 23, 2022

Study information

Verified date September 2022
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background : The supplementary motor area is the most common/preferential brain location of LGG. This area plays an important role in many motor and cognitive functions such as motor initiation, bimanual coordination and executive functions. Many studies describe the supplementary motor area syndrome resulting from lesions in this area. News managements for LGGs consisting in intraoperative mapping in awake patients reduce significantly neurological disorders and increase also the overall survival . However, the literature does not provide data concerning motor and cognitive functions in a long term and their consequences in the quality of life of patients. Objective : The aim of our research project is to identify whether there are some motor or neurocognitive deficit in the short and the long term in a population of patients who have medical story of LGG resection in the supplementary motor area.


Description:

Patients and Methods : 20 patients who have medical story of LGG in the supplementary motor area and 20 patients who have medical story of LGG resection in other locations are recruited. Firstly, patients have to complete a self-assessment questionnaire about their quality of life, sent by regular mail or e-mail. Then, patients are admitted on the same day as their follow up visit and underwent motor and neurocognitive screening tests ( "Bilan des 400 points", Tests of Attentional Performances) for an hour. The investigators will analyse data and compare between the 2 groups.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date June 23, 2022
Est. primary completion date June 23, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or older - Have a history of low-grade diffuse glioma resection - Visiting the University Hospital for a follow-up neurosurgical consultation - Underwent awake surgery Exclusion Criteria: - Presence of cognitive disorders that do not allow the proposed test battery to be performed - Under guardianship or curatorship - Opposition to the participation to the research

Study Design


Intervention

Other:
Test battery
motor and neuropsychological test battery

Locations

Country Name City State
France University hospital Tours

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary motor tests in the case group - 400 point assessment analysis of the scores obtained at the tests 4 tests :
Hand mobility
Grip strength
Single-handed grasp and movement of objects
Two-handed grasp and movement of objects Minimum value = 0 Maximum value = 100 100/100 means that the various tests regain good motor skills and hand grasp
inclusion visit
Primary neuropsychological tests in the case group analysis of the scores obtained Phase alert system
Reaction time (RT) and standard deviation (SD) measurement with horn
Measurement of reaction times (RT) and standard deviation(SD) without horn
Measurement of the phase alert index
Flexibility
Measurement of reaction times (RT) and standard deviation (SD) with hand change
Measurement of reaction times (RT) and standard deviation (SD) without hand change
Overall performance index
Speed accuracy trade off index
Number of wrong answers
Incompatibility
Measurement of reaction times (RT) and standard deviation (SD) in compatible condition
Measurement of reaction times (RT) and standard deviation (SD) in incompatible condition
F (visual field)
F (hand)
F (incompatibility: fields * hand)
Number of false responses
RT min : 0 SD min : 0 No maximum value: calculation against standard values
inclusion visit
Secondary motor tests in the control group - 400 point assessment analysis of the scores obtained at the tests 4 tests :
Hand mobility
Grip strength
Single-handed grasp and movement of objects
Two-handed grasp and movement of objects Minimum value = 0 Maximum value = 100 100/100 means that the various tests regain good motor skills and hand grasp
inclusion visit
Secondary neuropsychological tests in the control group analysis of the scores obtained Phase alert system
Reaction time (RT) and standard deviation (SD) measurement with horn
Measurement of reaction times (RT) and standard deviation(SD) without horn
Measurement of the phase alert index
Flexibility
Measurement of reaction times (RT) and standard deviation (SD) with hand change
Measurement of reaction times (RT) and standard deviation (SD) without hand change
Overall performance index
Speed accuracy trade off index
Number of wrong answers
Incompatibility
Measurement of reaction times (RT) and standard deviation (SD) in compatible condition
Measurement of reaction times (RT) and standard deviation (SD) in incompatible condition
F (visual field)
F (hand)
F (incompatibility: fields * hand)
Number of false responses
RT min : 0 SD min : 0 No maximum value: calculation against standard values
inclusion visit
Secondary Brain MRI Analysis of the location of diffuse low-grade gliomas inclusion visit
Secondary Brain MRI Analysis of the lesion volume of diffuse low-grade gliomas inclusion visit
Secondary quality of life self-questionnaire carried out at home : sickness Impact Profile analysis of the results obtained 136 questions with responses True or False Minimum value = 0 Maximum value = 136 136/136 means that the quality of life is very negatively affected inclusion visit
Secondary fatigue self-questionnaire carried out at home : fatigue Impact Scale (FIS) analysis of the results obtained 40 questions with responses
It is quite true
It is rather true
It is neither true nor false
It is rather false
It is completely false
inclusion visit
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