Cognitive DisordersPOG-CNCT05373394
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
An observational study of Cognitive Disorders and Motor Disorders, run by University Hospital, Tours at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Disorders, Motor Disorders, Low-grade Glioma
- What is being tested?
- Test battery
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2022to 23 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with low-grade diffuse glioma resection visiting the university hospital for a follow-up neurosurgical consultation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cognitive Disorders, Motor Disorders, Low-grade Glioma
- Being tested
- Test battery
- Keywords
- glioma, supplementary motor area, neurological disorders
- Medical subject headings
- Cognitive Dysfunction, Motor Disorders, Glioma, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test batteryOther
motor and neuropsychological test battery
| Study group | Role | What they receive |
|---|---|---|
| Case | patients with a history of surgical removal of diffuse low grade glioma located in the supplementary motor area Receives: Other: Test battery | |
| Control | patients with a history of surgical removal of diffuse low-grade glioma located in another brain area Receives: Other: Test battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: inclusion visit
Secondary outcomes (6)
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
Measured: 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
Measured: inclusion visit
Brain MRI
Analysis of the location of diffuse low-grade gliomas
Measured: inclusion visit
Brain MRI
Analysis of the lesion volume of diffuse low-grade gliomas
Measured: 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
Measured: 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
Measured: inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start19 May 2022
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilyess ZEMMOURA, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373394
- Sponsor's protocol ID
- DR220033
- Acronym
- POG-C
- Status last verified
- Sep 2022
- First submitted
- 2 May 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05373394
- Acronym / sponsor ID
- POG-C / DR220033
- Conditions
- Cognitive Disorders, Motor Disorders, Low-grade Glioma
- Keywords
- glioma, supplementary motor area, neurological disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 19 May 2022 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: Test batterypatients with a history of surgical removal of diffuse low grade glioma located in the supplementary motor area |
| Control | – | Other: Test batterypatients with a history of surgical removal of diffuse low-grade glioma located in another brain area |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with low-grade diffuse glioma resection visiting the university hospital for a follow-up neurosurgical consultation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test batterymotor and neuropsychological test battery | Other | Case, Control |
Primary outcome
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
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
6 secondary outcomes
motor tests in the control group - 400 point assessment
Time frame: inclusion visit
neuropsychological tests in the control group
Time frame: inclusion visit
Brain MRI
Time frame: inclusion visit
Brain MRI
Time frame: inclusion visit
quality of life self-questionnaire carried out at home : sickness Impact Profile
Time frame: inclusion visit
fatigue self-questionnaire carried out at home : fatigue Impact Scale (FIS)
Time frame: inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Cognitive Disorders
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilyess ZEMMOURA principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Disorders and Motor Disorders, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motor tests in the case group - 400 point assessment (time frame: inclusion visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.