Standardization of Spatial Neglect Assessment Tests
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-89
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy volunteer attending the neurovascular department of Raymond-Poincaré Hospital
Aged between 20 and 89 years
Affiliated with a health insurance scheme
French-speaking
Disqualifiers
Known history of central neurological disease: stroke (ischemic or hemorrhagic), transient ischemic attack, encephalitis, multiple sclerosis, or epilepsy.
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).
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.
National Institutes of Health Stroke Scale (NIHSS) score > 0
Trial design
Design model
Single group
Treatments tested in this trial
Neuropsychological assessment tests for spatial neglect
Other interventionStandardized administration of four paper-and-pencil tests designed to assess different forms of spatial neglect: * Apples Cancellation Test (Birmingham Cognitive Screen) for egocentric and allocentric neglect, * Simplified Comb and Razor Test for personal and motor neglect, * Line Bisection Test (30 cm ruler, blind version) for tactile neglect, * Dot Test for visual exploration. The purpose is to establish normative reference scores in healthy French-speaking adults according to age, sex, and professional qualification. No therapeutic intervention or patient population is involved.
Treatment groups
210 Participants
are divided into 1 treatment groupGroup A: groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To establish average scores for healthy French-speaking volunteers without central neurological disorders on the Apples Cancellation Test (from the BCoS), using French-translated administration and scoring instructions
The average scores for healthy French-speaking volunteers without central neurological disorders on the Apples Cancellation Test (from the BCoS), using French-translated administration instructions. The number of the box in which the first crossed-out apple is located, the total performance, the spatial asymmetry score (egocentric neglect), the object asymmetry score (allocentric neglect) and the passing time, in seconds.
Time frame
12 monthsSecondary outcomes
1
To establish average scores for healthy French-speaking volunteers without central neurological disorders on the simplified Comb and Razor Test, using French-language administration instructions
The average scores for healthy French-speaking volunteers without central neurological disorders on the simplified Comb and Razor Test, with French-language administration instructions.
Time frame
inclusion2
To establish average scores for healthy French-speaking volunteers without central neurological disorders on the Peg Test, according to their age, sex, and level of occupational qualification.
The average scores for healthy French-speaking volunteers without central neurological disorders on the Peg Test, according to their age, sex, and level of occupational qualification.
Time frame
inclusion3
To establish average scores for healthy French-speaking volunteers without central neurological disorders on the 30 cm blind line bisection test using an architect's ruler, according to their age, sex, and level of occupational qualification.
The average scores for healthy French-speaking volunteers without central neurological disorders on the 30 cm blind line bisection test using an architect's ruler, according to their age, sex, and level of occupational qualification.
Time frame
inclusionSponsors and contacts
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Source ClinicalTrials.gov