No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
20 – 89
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
210 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
Who this trial is looking for
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Spatial neglect is a common cognitive disorder in stroke patients, characterized by a lateralized deficit in attention and intention.
This research focuses on defining norms for tests to assess spatial neglect. The norms correspond to the results obtained in a population free of any disorder that could have an impact on test performance. These results can vary in a normal, non-pathological way, w…
Spatial neglect is a common cognitive disorder in stroke patients, characterized by a lateralized deficit in attention and intention.
This research focuses on defining norms for tests to assess spatial neglect. The norms correspond to the results obtained in a population free of any disorder that could have an impact on test performance. These results can vary in a normal, non-pathological way, with certain parameters such as age, sex, laterality or level of education. Defining these norms in healthy volunteers is therefore essential for interpreting results in patients suspected of spatial neglect, and in particular for defining pathological thresholds above which the diagnosis of spatial neglect can be retained.
To answer the research question, we plan to include 210 people with no central neurological disease (stroke, epilepsy and multiple sclerosis in particular), in a single-center study in the neurovascular department of the Raymond-Poincaré hospital (Garches). The 210 subjects will be divided into 10-year age groups, from 20 to 89 years, with the recruitment of 30 participants per age group (15 men and 15 women): 20-29 years, 30-39 years, 40-49 years, 50-59 years, 60-69 years, 70-79 years, 80-89 years.
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Eligibility Criteria
Inclusion Criteria:
1. Healthy volunteer attending the neurovascular department of Raymond-Poincaré Hospital
2. Aged between 20 and 89 years
3. Affiliated with a health insurance scheme
4. French-speaking
5. Has freely and knowingly expressed their non-opposition
Exclusion Criteria:
1. Known hist…
Inclusion Criteria:
1. Healthy volunteer attending the neurovascular department of Raymond-Poincaré Hospital
2. Aged between 20 and 89 years
3. Affiliated with a health insurance scheme
4. French-speaking
5. Has freely and knowingly expressed their non-opposition
Exclusion Criteria:
1. Known history of central neurological disease: stroke (ischemic or hemorrhagic), transient ischemic attack, encephalitis, multiple sclerosis, or epilepsy.
2. Medical interview suggesting past central nervous system involvement: history of episodes such as sensorimotor deficits, dysarthria, aphasia, blurred or double vision, or positive symptoms such as visual or sensory hallucinations (e.g., paresthesias).
3. Significant visual impairment - as judged by the examiner - in near vision despite correction, or monocular blindness. Specifically, inability to distinguish the targets with gaps in the example (pre-test) of the Apples Cancellation Test.
4. Abnormal neurological examination:
1. National Institutes of Health Stroke Scale (NIHSS) score \> 0
2. Pyramidal reflex syndrome (hyperactive deep tendon reflexes with extended reflexogenic zones and spread).
5. Use of substances (alcohol or drugs) within 24 hours prior to the assessment.
6. Presence of cognitive or psychiatric disorders, assessed during the inclusion interview and neurological examination, at the examiner's discretion.
7. Language barrier or aphasia, assessed during the inclusion interview and neurological examination, at the examiner's discretion.
8. Participant under legal protection (guardianship, curatorship, or legal safeguard).
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