Clinical trial NCT05373394: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Disorders
Motor Disorders
Low-grade Glioma
Keywords: glioma
supplementary motor area
neurological disorders
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2022-05-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with low-grade diffuse glioma resection visiting the university hospital for a follow-up neurosurgical consultation

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.

Eligibility criteria: 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

Primary outcomes:
measure: motor tests in the case group - 400 point assessment
timeFrame: inclusion visit
measure: neuropsychological tests in the case group
timeFrame: inclusion visit
Secondary outcomes:
measure: motor tests in the control group - 400 point assessment
timeFrame: inclusion visit
measure: neuropsychological tests in the control group
timeFrame: inclusion visit
measure: Brain MRI
timeFrame: inclusion visit
measure: Brain MRI
timeFrame: inclusion visit
measure: quality of life self-questionnaire carried out at home : sickness Impact Profile
timeFrame: inclusion visit
measure: fatigue self-questionnaire carried out at home : fatigue Impact Scale (FIS)
timeFrame: inclusion visit
Other outcomes:
Locations:
city: Tours
country: France
facility: University hospital
Study officials:
affiliation: University Hospital, Tours
name: Ilyess ZEMMOURA
role: PRINCIPAL_INVESTIGATOR
References: