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Evaluation of Cognitive and Motor Neurological Disorders in the Short and Long Term After Surgery for the Removal of a Diffuse Low-grade Glioma of the Supplementary Motor Area

Evaluation of Cognitive and Motor Neurological Disorders in the Short and Long Term After Surgery for the Removal of a Diffuse Low-grade Glioma of the Supplementary Motor Area

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05373394
Acronym
POG-C
Enrollment
22
Registered
2022-05-13
Start date
2022-05-19
Completion date
2022-06-23
Last updated
2022-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Disorders, Low-grade Glioma, Motor Disorders

Keywords

glioma, supplementary motor area, neurological disorders

Brief 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.

Detailed 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.

Interventions

motor and neuropsychological test battery

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
motor tests in the case group - 400 point assessmentinclusion visitanalysis 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
neuropsychological tests in the case groupinclusion visitanalysis 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

Secondary

MeasureTime frameDescription
Brain MRIinclusion visitAnalysis of the location of diffuse low-grade gliomas
motor tests in the control group - 400 point assessmentinclusion visitanalysis 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
fatigue self-questionnaire carried out at home : fatigue Impact Scale (FIS)inclusion visitanalysis 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
quality of life self-questionnaire carried out at home : sickness Impact Profileinclusion visitanalysis 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
neuropsychological tests in the control groupinclusion visitanalysis 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026