Cognitive Dysfunction Clinical Trial
— XO-SEPOfficial title:
Evaluation of a New Screening Test of Cognitive Impairment Among Multiple Sclerosis Patients
Even at the disease onset, about 70% of patients with multiple sclerosis (MS) suffer from
cognitive impairment that impacts quality of life. Currently, some speed processing tests are
used, such as SDMT ( symbol digit modalities test ), CSCT (information treatment speed
evaluation) and WAIS-IV (Weschler Adult Intelligence Scale ). Their inconvenient are the
improvement of scores in test-retest, and some difficulties doing the tests due to motor or
visual impairment that might be reported. The XO test is fast, cheap and easy to use during
medical consult by neurologists. It seems to be correlated to results of speed processing
tests, and probably to some executive functions tests too. Asthenia, anxiety, depression and
pain are likely to have a negative influence on tests results. Screening every patients with
a short test aims to detect patients with cognitive impairment earlier. After a positive
screening test, and to better characterize cognitive impairment, they will undergo a
neuropsychological test battery. Depending on the alteration, adapted workstation, financial
support, technical and human helps will be implemented in order to improve the daily-living
of patients.
This study aims to approve the XO as a screening test of cognitive impairment in MS patients.
We will study the relationship between XO test, and SDMT, CSCT, WAIS-IV, and also with
questionnaires about pain, asthenia (FSS, Fatigue Severity Scale), anxiety and depression
(HAD, Hospital Anxiety and Depression ). The XO test will be standardized using a healthy
population.
Status | Recruiting |
Enrollment | 540 |
Est. completion date | October 8, 2020 |
Est. primary completion date | September 8, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria : - Multiple sclerosis patients included must : - Be men or women aged 18 or more - Be diagnosed Multiple Sclerosis (MacDonald criteria, 2017) - No relapse in the previous month - Be mother-tongue French, or speaking French fluently - Be covered by French social security Healthy controls included must : - Be men or women aged 18 or more - Suffer from no pathology that might be incompatible with the study Exclusion criteria : - - Patients or controls declining participation to the study, or legally protected, pregnant or breastfeeding women - Patients suffering from another neurological disease, psychiatric disorder, or developmental abnormalities that were diagnosed before multiple sclerosis - Patients with cranial trauma, relapse that ended less than 1 month before, or depression less than 3 months - Patients with severe motor or visual disabilities |
Country | Name | City | State |
---|---|---|---|
France | CHU Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | Merck Santé SAS |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score of XO test | The score obtained doing XO test is the dependent variable that will be compared to the variables due to speed processing and executive functions tests. Test-retest of XO test will be also assessed. The percentage of wrong answers doing XO test will be investigated. | Day 0 | |
Secondary | Score of anxiety | Every patients and healthy control will fill in the HAD questionnaire, exploring both anxiety and depression. It is composed of 7 questions ranged from 0 to 3. The test score is ranged from 0 to 21. Higher values are correlated to worse outcome.The score of anxiety is an independent variable that will be compare to score of XO test. | Day 0 | |
Secondary | Score of depression | Every patients and healthy control will fill in the HAD questionnaire, exploring both anxiety and depression. It is composed of 7 questions ranged from 0 to 3. The test score is ranged from 0 to 21. Higher values are correlated to worse outcome.The score of depression is an independent variable that will be compare to score of XO test. | Day 0 | |
Secondary | Score of asthenia | Every patients and healthy control will fill in the FSS (fatigue severity scale) questionnaire, exploring asthenia in Multiple Sclerosis patients. It is composed of 9 questions ranged from 1 to 7. The test score is ranged from 9 to 63. Higher values are correlated to worse outcome. The score of asthenia is an independent variable that will be compared to score of XO test. | Day 0 | |
Secondary | Score of pain | Every patients and healthy control will fill in a pain questionnaire, exploring both cephalalgia, nociceptive and neuropathic pain. It is composed of 22 questions. Some questions must be answered by "yes" or "no". Some other questions are using a visual analogue pain scale from 0 to 10, where 10 is the worse outcome. Some questions need to write the topography of the pain, and the treatment used. Every answer to the questionnaire of pain is an independent variable that will be compare to score of XO test. | Day 0 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05273125 -
MOBility Disorders Assessment in Patients With Mild COGnitive Disorders
|
||
Active, not recruiting |
NCT04049695 -
Improving Cognition After Cancer
|
N/A | |
Completed |
NCT05912374 -
Adapting a Behavioral Intervention to Accommodate Cognitive Dysfunction in People Who Inject Drugs
|
N/A | |
Recruiting |
NCT03977350 -
Association Between qEEG Measure and Post-Operative Cognitive Dysfunction (POCD) and Postoperative Delirium (POD)
|
||
Not yet recruiting |
NCT06027632 -
Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer
|
N/A | |
Terminated |
NCT00754052 -
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17
|
Phase 3 | |
Completed |
NCT00719628 -
Depth of Anaesthesia and Cognitive Dysfunction
|
N/A | |
Terminated |
NCT00754013 -
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10
|
Phase 3 | |
Recruiting |
NCT05014399 -
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
|
||
Completed |
NCT04966455 -
Effect of Raisins on Cognitive Function in Healthy Older Adults
|
Phase 3 | |
Recruiting |
NCT05372159 -
Vanderbilt Memory and Aging Project
|
||
Completed |
NCT03243279 -
BRS and Outcomes in Cardiothoracic Surgery
|
||
Completed |
NCT04093882 -
The Relevance of the Blood-brain Barrier to Cognitive Dysfunction and Alzheimer's Disease
|
||
Recruiting |
NCT05732285 -
A Pilot Randomized Controlled Trial: CoINTEGRATE
|
N/A | |
Completed |
NCT06059768 -
Urdu Translation and Psychometric Analysis of Lawton IADLS.
|
||
Completed |
NCT04562662 -
Evaluation of mediVR-KAGURA Guided Therapy
|
N/A | |
Completed |
NCT04624529 -
Validity and Reliability of a Self-evaluation Tool for Cognitive Deficits in the Acute Stage After Stroke
|
||
Not yet recruiting |
NCT04079075 -
Multiple Interventions to Prevent Cognitive Decline
|
N/A | |
Active, not recruiting |
NCT04638101 -
Building the Path to Resilience in Preterm Infants: Mindfulness-based Intervention
|
N/A | |
Active, not recruiting |
NCT04556305 -
Lifestyle Physical Activity and Cognitive Training Interventions
|
N/A |