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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05268159
Other study ID # HLJ_2022_02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2011
Est. completion date December 31, 2021

Study information

Verified date February 2022
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospective cohort study of consecutive patients investigated in a neurorehabilitation ward after a first hemispheric stroke. Unilateral spatial Neglect (USN) and other cognitive impairments (including attention, executive functions, memory) have been assessed in routine care at the subacute phase (<6 months). MRI scans have also been done in routine care. The study aims at linking lesion characteristics, disconnections induced and expression of the different modalities of USN


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - First hemispheric adult stroke patient - Non-opposed to inclusion - Confirmed by MRI - Assessment of cognitive functions during the subacute phase (3 weeks to 6 months after stroke onset Exclusion Criteria: - History of previous stroke or neurological disorders - Inability to perform cognitive assessment due to severe comprehension, cognitive or psychiatric disorder - Uncorrected severe loss of visual acuity - Contra-indications to MRI

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cognitive assessment
Assessment of unilateral spatial neglect, attention, executive functions and memory

Locations

Country Name City State
France Hop Swynghedauw Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of peripersonal Unilateral Neglect with the BEN (Batterie d'évaluation de la negligence, Battery of tests for the quantitative assessment of unilateral neglect) One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Secondary Assessment of personal Unilateral Spatial Neglect with the Fluff Test One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Secondary Assessment of personal Unilateral Spatial Neglect with the Comb and Razor Test One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Secondary Assessment of Attention with the Test of Attentional Performance One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Secondary Assessment of Executive Functions with the Stroop Test One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Secondary Assessment of Executive Functions with the Trail Making Test One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Secondary Assessment of Executive Function with Verbal and Categorial Fluency test One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Secondary Assessment of Executive Functions with the test of commissions One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Secondary Assessment of verbal Memory with the verbal span task One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Secondary Assessment of verbal Memory with the Grober and Buschke Task One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Secondary Assessment of visual Memory with the Doors test One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Secondary Assessment of visual Memory with the Rey figure test One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Secondary Identification of brain lesions by Anatomical MRI (T1, FLAIR, T2*, Diffusion) up to 6 months
Secondary Postural assessment with the PASS 1 month after stroke
Secondary Postural assessment with the PASS 3 months after stroke
Secondary Gait assessment (Lindmark score) 1 month after stroke
Secondary Gait assessment (Lindmark score) 3 months after stroke
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