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 (POG-C)

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.

Study Overview

• Status: Completed
• Conditions: Motor Disorders; Low-grade Glioma; Cognitive Disorders
• Intervention / Treatment: Other: Test battery

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.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case; patients with a history of surgical removal of diffuse low grade glioma located in the supplementary motor area	Other: Test battery; motor and neuropsychological test battery
Control; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Brain MRI	Analysis of the location of diffuse low-grade gliomas	inclusion visit
Brain MRI	Analysis of the lesion volume of diffuse low-grade gliomas	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	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	inclusion visit

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Ilyess ZEMMOURA, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): June 23, 2022

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: glioma; neurological disorders; supplementary motor area
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neurocognitive Disorders; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Disease; Glioma; Nervous System Diseases; Cognition Disorders; Motor Disorders
• Other Study ID Numbers: DR220033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No