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

Motor Disorders Clinical Trial

— POG-C  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05373394
• Other study ID #: DR220033
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Disorders
• Disease
• Glioma
• Low-grade Glioma
• Motor Disorders
• Nervous System Diseases

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