An observational study in Cognitive Disorders, Motor Disorders and Low-grade Glioma, sponsored by University Hospital, Tours. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-07.
Sponsored by University Hospital, Tours · Observational
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.
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.
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
This study's enrollment of 22 is below the median of 88 across 238 observational studies indexed under Glioma.
Browse Glioma studies →University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.
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Adult patients with low-grade diffuse glioma resection visiting the university hospital for a follow-up neurosurgical consultation
Exclusion Criteria:
patients with a history of surgical removal of diffuse low grade glioma located in the supplementary motor area
Other: Test battery
patients with a history of surgical removal of diffuse low-grade glioma located in another brain area
Other: Test battery
motor and neuropsychological test battery
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
Time frame: inclusion visit
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
Time frame: inclusion visit
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
Time frame: inclusion visit
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
Time frame: inclusion visit
Brain MRI
Analysis of the location of diffuse low-grade gliomas
Time frame: inclusion visit
Brain MRI
Analysis of the lesion volume of diffuse low-grade gliomas
Time frame: inclusion visit
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
Time frame: inclusion visit
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
Time frame: inclusion visit
Plan to share: Undecided
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University Hospital, Tours