Stroke Clinical Trial
— DISCONEGLECTOfficial title:
Neural Basis of Unilateral Spatial Neglect After Stroke: a Retrospective Disconnectome Based Study
| 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 |
| Verified date | February 2022 |
| Source | University Hospital, Lille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hop Swynghedauw | Lille |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Lille |
France,
| 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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