Clinical trial NCT05268159: Disconnection and Unilateral Spatial Neglect
Official title: Neural Basis of Unilateral Spatial Neglect After Stroke: a Retrospective Disconnectome Based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
Unilateral spatial neglect
MRI
Disconnectome,
Cognition
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients admitted in neurorehabilitation ward after first hemispheric stroke

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of peripersonal Unilateral Neglect with the BEN (Batterie d'évaluation de la negligence, Battery of tests for the quantitative assessment of unilateral neglect)
timeFrame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Secondary outcomes:
measure: Assessment of personal Unilateral Spatial Neglect with the Fluff Test
timeFrame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
measure: Assessment of personal Unilateral Spatial Neglect with the Comb and Razor Test
timeFrame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
measure: Assessment of Attention with the Test of Attentional Performance
timeFrame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
measure: Assessment of Executive Functions with the Stroop Test
timeFrame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
measure: Assessment of Executive Functions with the Trail Making Test
timeFrame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
measure: Assessment of Executive Function with Verbal and Categorial Fluency test
timeFrame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
measure: Assessment of Executive Functions with the test of commissions
timeFrame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
measure: Assessment of verbal Memory with the verbal span task
timeFrame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
measure: Assessment of verbal Memory with the Grober and Buschke Task
timeFrame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
measure: Assessment of visual Memory with the Doors test
timeFrame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
measure: Assessment of visual Memory with the Rey figure test
timeFrame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
measure: Identification of brain lesions by Anatomical MRI (T1, FLAIR, T2*, Diffusion)
timeFrame: up to 6 months
measure: Postural assessment with the PASS
timeFrame: 1 month after stroke
measure: Postural assessment with the PASS
timeFrame: 3 months after stroke
measure: Gait assessment (Lindmark score)
timeFrame: 1 month after stroke
measure: Gait assessment (Lindmark score)
timeFrame: 3 months after stroke
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Swynghedauw
Study officials:
affiliation: University Hospital, Lille
name: Etienne Allart, MD
role: PRINCIPAL_INVESTIGATOR
References: