StrokeDISCONEGLECTNCT05268159
Disconnection and Unilateral Spatial Neglect
An observational study of Stroke, run by University Hospital, Lille at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Cognitive assessment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2011to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients admitted in neurorehabilitation ward after first hemispheric stroke
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Stroke
- Being tested
- Cognitive assessment
- Keywords
- Stroke, Unilateral spatial neglect, MRI, Disconnectome,, Cognition
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive assessmentOther
Assessment of unilateral spatial neglect, attention, executive functions and memory
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Stroke patients admitted to the Lille Neurological rehabilitation unit after a first-ever hemispheric stroke, assessed at the subacute phase (< 6months) Receives: Other: Cognitive assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of peripersonal Unilateral Neglect with the BEN (Batterie d'évaluation de la negligence, Battery of tests for the quantitative assessment of unilateral neglect)
Measured: 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
Measured: 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
Measured: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of Attention with the Test of Attentional Performance
Measured: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of Executive Functions with the Stroop Test
Measured: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of Executive Functions with the Trail Making Test
Measured: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of Executive Function with Verbal and Categorial Fluency test
Measured: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of Executive Functions with the test of commissions
Measured: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of verbal Memory with the verbal span task
Measured: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of verbal Memory with the Grober and Buschke Task
Measured: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of visual Memory with the Doors test
Measured: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Assessment of visual Memory with the Rey figure test
Measured: One assessment, during the subacute phase after stroke (3 weeks to 6 months)
Identification of brain lesions by Anatomical MRI (T1, FLAIR, T2*, Diffusion)
Measured: up to 6 months
Postural assessment with the PASS
Measured: 1 month after stroke
Postural assessment with the PASS
Measured: 3 months after stroke
Gait assessment (Lindmark score)
Measured: 1 month after stroke
Gait assessment (Lindmark score)
Measured: 3 months after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 Jun 2011
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne Allart, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268159
- Sponsor's protocol ID
- HLJ_2022_02
- Acronym
- DISCONEGLECT
- Status last verified
- Feb 2022
- First submitted
- 24 Feb 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Basis of Unilateral Spatial Neglect After Stroke: a Retrospective Disconnectome Based Study
- ClinicalTrials.gov ID
- NCT05268159
- Acronym / sponsor ID
- DISCONEGLECT / HLJ_2022_02
- Conditions
- Stroke
- Keywords
- Stroke, Unilateral spatial neglect, MRI, Disconnectome,, Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Other: Cognitive assessmentStroke patients admitted to the Lille Neurological rehabilitation unit after a first-ever hemispheric stroke, assessed at the subacute phase (< 6months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients admitted in neurorehabilitation ward after first hemispheric stroke
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive assessmentAssessment of unilateral spatial neglect, attention, executive functions and memory | Other | Stroke patients |
Primary outcome
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)
16 secondary outcomes
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)
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)
Assessment of Attention with the Test of Attentional Performance
Time frame: 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)
Assessment of Executive Functions with the Trail Making Test
Time frame: 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)
Assessment of Executive Functions with the test of commissions
Time frame: 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)
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)
Assessment of visual Memory with the Doors test
Time frame: 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)
Identification of brain lesions by Anatomical MRI (T1, FLAIR, T2*, Diffusion)
Time frame: up to 6 months
Postural assessment with the PASS
Time frame: 1 month after stroke
Postural assessment with the PASS
Time frame: 3 months after stroke
Gait assessment (Lindmark score)
Time frame: 1 month after stroke
Gait assessment (Lindmark score)
Time frame: 3 months after stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
Related trials for Stroke
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne Allart, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: One assessment, during the subacute phase after stroke (3 weeks to 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.