Motor Disorders Clinical Trial
— POG-COfficial 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
NCT number | NCT05373394 |
Other study ID # | DR220033 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 19, 2022 |
Est. completion date | June 23, 2022 |
Verified date | September 2022 |
Source | University Hospital, Tours |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | University hospital | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours |
France,
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 |
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