NCT05268159

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
Last Updated

May 18, 2022

Status Verified

February 1, 2022

Enrollment Period

10.6 years

First QC Date

February 24, 2022

Last Update Submit

May 17, 2022

Conditions

Keywords

StrokeUnilateral spatial neglectMRIDisconnectome,Cognition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Assessment of personal Unilateral Spatial Neglect with the Fluff Test

    One assessment, during the subacute phase after stroke (3 weeks to 6 months)

  • 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)

  • Assessment of Attention with the Test of Attentional Performance

    One assessment, during the subacute phase after stroke (3 weeks to 6 months)

  • Assessment of Executive Functions with the Stroop Test

    One assessment, during the subacute phase after stroke (3 weeks to 6 months)

  • Assessment of Executive Functions with the Trail Making Test

    One assessment, during the subacute phase after stroke (3 weeks to 6 months)

  • +11 more secondary outcomes

Study Arms (1)

Stroke patients

Stroke patients admitted to the Lille Neurological rehabilitation unit after a first-ever hemispheric stroke, assessed at the subacute phase (\< 6months)

Other: Cognitive assessment

Interventions

Assessment of unilateral spatial neglect, attention, executive functions and memory

Stroke patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients admitted in neurorehabilitation ward after first hemispheric stroke

You may qualify if:

  • First hemispheric adult stroke patient
  • Confirmed by MRI
  • Assessment of cognitive functions during the subacute phase (3 weeks to 6 months after stroke onset

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hop Swynghedauw

Lille, 59000, France

Location

MeSH Terms

Conditions

Stroke

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Etienne Allart, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2022

First Posted

March 7, 2022

Study Start

June 1, 2011

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 18, 2022

Record last verified: 2022-02

Locations