Disconnection and Unilateral Spatial Neglect (DISCONEGLECT)

May 17, 2022 updated by: University Hospital, Lille

Neural Basis of Unilateral Spatial Neglect After Stroke: a Retrospective Disconnectome Based Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59000
        • Hop Swynghedauw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients admitted in neurorehabilitation ward after first hemispheric stroke

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Assessment of unilateral spatial neglect, attention, executive functions and memory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of peripersonal Unilateral Neglect with the BEN (Batterie d'évaluation de la negligence, Battery of tests for the quantitative assessment of unilateral neglect)
Time Frame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
One assessment, during the subacute phase after stroke (3 weeks to 6 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of personal Unilateral Spatial Neglect with the Fluff Test
Time Frame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
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
Time Frame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of Attention with the Test of Attentional Performance
Time Frame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of Executive Functions with the Stroop Test
Time Frame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of Executive Functions with the Trail Making Test
Time Frame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of Executive Function with Verbal and Categorial Fluency test
Time Frame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of Executive Functions with the test of commissions
Time Frame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of verbal Memory with the verbal span task
Time Frame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of verbal Memory with the Grober and Buschke Task
Time Frame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of visual Memory with the Doors test
Time Frame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of visual Memory with the Rey figure test
Time Frame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Identification of brain lesions by Anatomical MRI (T1, FLAIR, T2*, Diffusion)
Time Frame: up to 6 months
up to 6 months
Postural assessment with the PASS
Time Frame: 1 month after stroke
1 month after stroke
Postural assessment with the PASS
Time Frame: 3 months after stroke
3 months after stroke
Gait assessment (Lindmark score)
Time Frame: 1 month after stroke
1 month after stroke
Gait assessment (Lindmark score)
Time Frame: 3 months after stroke
3 months after stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2011

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

March 4, 2022

First Posted (ACTUAL)

March 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLJ_2022_02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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