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Completed

NCT Number: 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

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.

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Key information

Conditions

Cognitive Disorders Cognition Disorders Cognitive Dysfunction Glioma Low-grade Glioma Mental Disorders Motor Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Neurocognitive Disorders Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test Battery

Other

motor and neuropsychological test battery

Primary outcomes

  1. motor tests in the case group - 400 point assessment

    Time frame: inclusion visit

    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

  2. neuropsychological tests in the case group

    Time frame: inclusion visit

    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

Secondary outcomes

  1. motor tests in the control group - 400 point assessment

    Time frame: inclusion visit

    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

  2. neuropsychological tests in the control group

    Time frame: inclusion visit

    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

  3. Brain MRI

    Time frame: inclusion visit

    Analysis of the location of diffuse low-grade gliomas

  4. Brain MRI

    Time frame: inclusion visit

    Analysis of the lesion volume of diffuse low-grade gliomas

  5. quality of life self-questionnaire carried out at home : sickness Impact Profile

    Time frame: inclusion visit

    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

  6. fatigue self-questionnaire carried out at home : fatigue Impact Scale (FIS)

    Time frame: inclusion visit

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: POG-C

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 13, 2022
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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