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
1 other identifier
observational
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2022
CompletedFirst Posted
Study publicly available on registry
May 13, 2022
CompletedStudy Start
First participant enrolled
May 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2022
CompletedSeptember 7, 2022
September 1, 2022
1 month
May 2, 2022
September 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
motor tests in the control group - 400 point assessment
inclusion visit
neuropsychological tests in the control group
inclusion visit
Brain MRI
inclusion visit
Brain MRI
inclusion visit
quality of life self-questionnaire carried out at home : sickness Impact Profile
inclusion visit
- +1 more secondary outcomes
Study Arms (2)
Case
patients with a history of surgical removal of diffuse low grade glioma located in the supplementary motor area
Control
patients with a history of surgical removal of diffuse low-grade glioma located in another brain area
Interventions
Eligibility Criteria
Adult patients with low-grade diffuse glioma resection visiting the university hospital for a follow-up neurosurgical consultation
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University hospital
Tours, 37044, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilyess ZEMMOURA
University Hospital, Tours
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2022
First Posted
May 13, 2022
Study Start
May 19, 2022
Primary Completion
June 23, 2022
Study Completion
June 23, 2022
Last Updated
September 7, 2022
Record last verified: 2022-09