AnosognosiaNCT05654350
Lesion Site and Neglect Anosognosia in Patients With Left Hemispatial Neglect
An observational study of Anosognosia and Neglect, Hemispatial, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this retrospective is to investigate the relationship between lesion site and neglect anosognosia in subacute or chronic right hemispheric stroke patients with left hemispatial neglect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anosognosia, Neglect, Hemispatial, Stroke
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2022to 21 Jan 2023
- 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: Patients with subacute or chronic right hemispheric stroke with left hemispatial neglect
Who may be able to join
- Being older than 18 years of age
- Having a subacute or chronic right hemispheric supratentorial stroke
- Having left hemispatial neglect
Who cannot join
- Being in the first 2 weeks of the stroke
- Lesions involving the left hemisphere and/or brainstem and/or cerebellum
- Having other neurological conditions such as traumatic brain injury, central nervous system neoplasm, neurodegenerative or neuropsychiatric diseases
- Presence of severe cognitive impairment in the mini-mental state examination scale (<10 points)
- Lack of brain imaging data
- Having visual problems and psychiatric disorders hindering neglect and anosognosia evaluation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Hospital, Department of Physical Medicine and Rehabilitation
Ankara, 06560
About this study
Official title: The Relationship Between Lesion Site And Neglect Anosognosia in Right Hemispheric Stroke Patients With Left Hemispatial Neglect
The goal of this retrospective is to investigate the relationship between lesion site and neglect anosognosia in subacute or chronic right hemispheric stroke patients with left hemispatial neglect. The main questions it aims to answer are:
- Was any lesion site related to a higher neglect anosognosia rate?
- Did any lesion site related to a more severe neglect anosognosia? Participants will be divided into two groups regarding the presence of anosognosia for spatial neglect.
Researchers will compare patients with and without anosognosia to see if any lesion site resulted in a higher anosognosia rate and more severe unawareness of neglect symptoms in daily life.
Read the detailed description
Babinski first defined anosognosia in 1914 as being unaware of paralysis in patients with right hemisphere stroke. Today, this term is used for the unawareness of various neurological and cognitive diseases or disabilities. One of these, anosognosia for hemispatial neglect, is an interesting phenomenon and has not been explored as thoroughly as hemiplegia anosognosia. Lesions of the right superior and inferior temporal gyrus, temporoparietal junction, and insula have been blamed for hemiplegia anosognosia. However, the neural correlates of neglect anosognosia are yet to be elucidated. Therefore, in this study, the investigators aim to investigate the relationship between lesion site and neglect anosognosia in subacute or chronic right hemispheric stroke patients with left hemispatial neglect.
In this retrospective study, the investigators will screen the medical records of our inpatient cognitive rehabilitation unit from 2011 to 2021. Patients diagnosed with left hemispatial neglect using Catherine Bergego Scale (CBS), line bisection, star cancellation, figure and shape copying, or representational drawing tests will be included in the study. Demographic and clinical data such as age, gender, weeks after stroke, stroke type (ischemic or hemorrhagic), lesion site, Brunnstrom stages, mini-mental status examination score and severities of neglect and neglect anosognosia will be noted.
Both neglect and neglect anosognosia severities will be determined using CBS. The underestimation of spatial deficits in daily living detected by parallel CBS testing will be considered as neglect anosognosia. The neglect anosognosia score will be calculated by subtracting the patient's self-assessment score from the evaluator-assigned CBS score. A difference of at least one point will be considered the presence of anosognosia. Patients will be divided into two groups with and without anosognosia according to the CBS-anosognosia score. Demographic and clinical features of patients with and without anosognosia will be compared. The correlation between neglect and neglect anosognosia scores will be examined.
The lesion site will be described by regions of interest (ROI) involvement using a semi-quantitative analyse. The association between anosognosia presence and involvement of the ROI will be analysed using the odds ratio with %95 confidence intervals. Neglect and anosognosia severities will also be compared between involvement and sparing of each ROI. Mini-mental state examination scores will be compared between the groups with and without anosognosia to address mental status, which may be a confounding factor in the evaluation of anosognosia.
- Conditions
- Anosognosia, Neglect, Hemispatial, Stroke, Neurobehavioral Problems
- Keywords
- Neglect anosognosia, Stroke, Hemispatial neglect, Self-awareness, Anosognosia
- Medical subject headings
- Agnosia, Perceptual Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with neglect anosognosia | Subacute or chronic right hemispheric stroke patients with left hemispatial neglect and neglect anosognosia. | |
| Patients without neglect anosognosia | Subacute or chronic right hemispheric stroke patients with left hemispatial neglect but no neglect anosognosia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neglect Score on Catherine Bergego Scale (CBS)
CBS-neglect score, which was assigned by an experienced rehabilitation nurse, will be obtained. CBS is a 10-item questionnaire based on direct observation of the patient's activities of daily living such as grooming, dressing, eating, cleaning mouth after a meal, gaze orientation, left limb knowledge, auditory attention, colliding when moving, spatial orientation and, finding belongings. Each item is scored on a 4-point scale ranging from 0 (no ignore) to 3 (severe ignore). The total score ranges from 0 to 30. Higher scores represent more severe spatial neglect behaviour.
Measured: Within the first week of admission to the inpatient rehabilitation clinic
Neglect Anosognosia Score on Catherine Bergego Scale (CBS)
CBS is a parallel test in which patients can evaluate themselves while an external observer evaluates the patient. The CBS-neglect anosognosia score is calculated by subtracting the patient's self-assessment score from the score given by the external observer for each CBS item. The anosognosia score ranges from 0 to 3 for each item and 0 to 30 in total. Higher scores represent more severe neglect anosognosia.
Measured: Within the first week of admission to the inpatient rehabilitation clinic
Lesion site-cortical involvement
A semi-quantitative lesion analysis will be conducted on brain magnetic resonance or computed tomography imaging records. Lesions will be scored as 1 or 0, respectively, as those with and without cortical involvement. The frequency of lesions with cortical involvement will be determined.
Measured: Within the first week of admission to the inpatient rehabilitation clinic
Lesion site-regions of interest
A semi-quantitative lesion analysis will be conducted on brain magnetic resonance or computed tomography imaging records. Lesions will be scored as 1 and 0, respectively, with and without the involvement of each region of interest (ROI). Seven ROIs have been identified: frontal, parietal, temporal, occipital, insula, basal ganglia, and thalamus. The frequencies will be determined for each ROI involvement. The frequency of lesions involving multiple ROIs will also be noted.
Measured: Within the first week of admission to the inpatient rehabilitation clinic
Lesion pervasiveness
A semi-quantitative lesion analysis will be conducted on brain magnetic resonance or computed tomography imaging records. The total scores of ROIs involved will define the lesion pervasiveness score. It will range from 0 to 7, with a higher score representing a more pervasive lesion.
Measured: Within the first week of admission to the inpatient rehabilitation clinic
Secondary outcomes (1)
Turkish version of the Mini-Mental State Examination (MMSE)
Turkish version of the Mini-Mental State Examination (MMSE) is a scale used to evaluate the cognitive status of individuals. It evaluates verbal responses including attention, orientation and memory; the abilities to follow verbal and written orders, write spontaneous sentences, and copy a complex drawing. The score is the number of items answered correctly, giving a total of 0 to 30 points. A score of 23 or less is the accepted cut-off point for cognitive impairment. The lower score represents a more severe cognitive impairment. The reliability and validity studies of the Turkish version of the MMSE were performed by Güngen et al. in 2002.
Measured: Within the first week of admission to the inpatient rehabilitation clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start16 Dec 2022
- Primary completion20 Jan 2023
- Study completion21 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AnosognosiaStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Levent Karataş, Gazi University
- Investigators
- Gülçin Kaymak Karataş, MD, Principal investigator, Gazi University Faculty of MedicineLevent Karataş, MD, Principal investigator, Gazi University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654350
- Sponsor's protocol ID
- Anosognosia and lesion site
- Status last verified
- Dec 2022
- First submitted
- 29 Nov 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langer KG, Bogousslavsky J. The Merging Tracks of Anosognosia and Neglect. Eur Neurol. 2020;83(4):438-446. doi: 10.1159/000510397. Epub 2020 Sep 14.
PubMed 32927461Jehkonen M, Laihosalo M, Kettunen J. Anosognosia after stroke: assessment, occurrence, subtypes and impact on functional outcome reviewed. Acta Neurol Scand. 2006 Nov;114(5):293-306. doi: 10.1111/j.1600-0404.2006.00723.x.
PubMed 17022776Heilman KM. Possible mechanisms of anosognosia of hemiplegia. Cortex. 2014 Dec;61:30-42. doi: 10.1016/j.cortex.2014.06.007. Epub 2014 Jun 19.
PubMed 25023619Vossel S, Weiss PH, Eschenbeck P, Saliger J, Karbe H, Fink GR. The neural basis of anosognosia for spatial neglect after stroke. Stroke. 2012 Jul;43(7):1954-6. doi: 10.1161/STROKEAHA.112.657288. Epub 2012 May 24.
PubMed 22627992Rousseaux M, Allart E, Bernati T, Saj A. Anatomical and psychometric relationships of behavioral neglect in daily living. Neuropsychologia. 2015 Apr;70:64-70. doi: 10.1016/j.neuropsychologia.2015.02.011. Epub 2015 Feb 10.
PubMed 25676676Karnath HO, Baier B. Right insula for our sense of limb ownership and self-awareness of actions. Brain Struct Funct. 2010 Jun;214(5-6):411-7. doi: 10.1007/s00429-010-0250-4. Epub 2010 May 29.
PubMed 20512380Laporta-Hoyos O, Fiori S, Pannek K, Ballester-Plane J, Leiva D, Reid LB, Pagnozzi AM, Vazquez E, Delgado I, Macaya A, Pueyo R, Boyd RN. Brain lesion scores obtained using a simple semi-quantitative scale from MR imaging are associated with motor function, communication and cognition in dyskinetic cerebral palsy. Neuroimage Clin. 2018 Jun 14;19:892-900. doi: 10.1016/j.nicl.2018.06.015. eCollection 2018.
PubMed 30013928Pia L, Neppi-Modona M, Ricci R, Berti A. The anatomy of anosognosia for hemiplegia: a meta-analysis. Cortex. 2004 Apr;40(2):367-77. doi: 10.1016/s0010-9452(08)70131-x.
PubMed 15156794
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Lesion Site And Neglect Anosognosia in Right Hemispheric Stroke Patients With Left Hemispatial Neglect
- ClinicalTrials.gov ID
- NCT05654350
- Acronym / sponsor ID
- Anosognosia and lesion site
- Conditions
- Anosognosia, Neglect, Hemispatial, Stroke, Neurobehavioral Problems
- Keywords
- Neglect anosognosia, Stroke, Hemispatial neglect, Self-awareness, Anosognosia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 21 Jan 2023 (actual)
- First posted
- 16 Dec 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.
The goal of this retrospective is to investigate the relationship between lesion site and neglect anosognosia in subacute or chronic right hemispheric stroke patients with left hemispatial neglect. The main questions it aims to answer are:
- Was any lesion site related to a higher neglect anosognosia rate?
- Did any lesion site related to a more severe neglect anosognosia? Participants will be divided into two groups regarding the presence of anosognosia for spatial neglect.
Researchers will compare patients with and without anosognosia to see if any lesion site resulted in a higher anosognosia rate and more severe unawareness of neglect symptoms in daily life.
Detailed description
Babinski first defined anosognosia in 1914 as being unaware of paralysis in patients with right hemisphere stroke. Today, this term is used for the unawareness of various neurological and cognitive diseases or disabilities. One of these, anosognosia for hemispatial neglect, is an interesting phenomenon and has not been explored as thoroughly as hemiplegia anosognosia. Lesions of the right superior and inferior temporal gyrus, temporoparietal junction, and insula have been blamed for hemiplegia anosognosia. However, the neural correlates of neglect anosognosia are yet to be elucidated. Therefore, in this study, the investigators aim to investigate the relationship between lesion site and neglect anosognosia in subacute or chronic right hemispheric stroke patients with left hemispatial neglect.
In this retrospective study, the investigators will screen the medical records of our inpatient cognitive rehabilitation unit from 2011 to 2021. Patients diagnosed with left hemispatial neglect using Catherine Bergego Scale (CBS), line bisection, star cancellation, figure and shape copying, or representational drawing tests will be included in the study. Demographic and clinical data such as age, gender, weeks after stroke, stroke type (ischemic or hemorrhagic), lesion site, Brunnstrom stages, mini-mental status examination score and severities of neglect and neglect anosognosia will be noted.
Both neglect and neglect anosognosia severities will be determined using CBS. The underestimation of spatial deficits in daily living detected by parallel CBS testing will be considered as neglect anosognosia. The neglect anosognosia score will be calculated by subtracting the patient's self-assessment score from the evaluator-assigned CBS score. A difference of at least one point will be considered the presence of anosognosia. Patients will be divided into two groups with and without anosognosia according to the CBS-anosognosia score. Demographic and clinical features of patients with and without anosognosia will be compared. The correlation between neglect and neglect anosognosia scores will be examined.
The lesion site will be described by regions of interest (ROI) involvement using a semi-quantitative analyse. The association between anosognosia presence and involvement of the ROI will be analysed using the odds ratio with %95 confidence intervals. Neglect and anosognosia severities will also be compared between involvement and sparing of each ROI. Mini-mental state examination scores will be compared between the groups with and without anosognosia to address mental status, which may be a confounding factor in the evaluation of anosognosia.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with neglect anosognosia | – | –Subacute or chronic right hemispheric stroke patients with left hemispatial neglect and neglect anosognosia. |
| Patients without neglect anosognosia | – | –Subacute or chronic right hemispheric stroke patients with left hemispatial neglect but no neglect anosognosia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with subacute or chronic right hemispheric stroke with left hemispatial neglect
Key inclusion criteria (3 listed)
- Being older than 18 years of age
- Having a subacute or chronic right hemispheric supratentorial stroke
- Having left hemispatial neglect
Key exclusion criteria (6 listed)
- Being in the first 2 weeks of the stroke
- Lesions involving the left hemisphere and/or brainstem and/or cerebellum
- Having other neurological conditions such as traumatic brain injury, central nervous system neoplasm, neurodegenerative or neuropsychiatric diseases
- Presence of severe cognitive impairment in the mini-mental state examination scale (<10 points)
- Lack of brain imaging data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neglect Score on Catherine Bergego Scale (CBS)
Time frame: Within the first week of admission to the inpatient rehabilitation clinic
CBS-neglect score, which was assigned by an experienced rehabilitation nurse, will be obtained. CBS is a 10-item questionnaire based on direct observation of the patient's activities of daily living such as grooming, dressing, eating, cleaning mouth after a meal, gaze orientation, left limb knowledge, auditory attention, colliding when moving, spatial orientation and, finding belongings. Each item is scored on a 4-point scale ranging from 0 (no ignore) to 3 (severe ignore). The total score ranges from 0 to 30. Higher scores represent more severe spatial neglect behaviour.
Neglect Anosognosia Score on Catherine Bergego Scale (CBS)
Time frame: Within the first week of admission to the inpatient rehabilitation clinic
CBS is a parallel test in which patients can evaluate themselves while an external observer evaluates the patient. The CBS-neglect anosognosia score is calculated by subtracting the patient's self-assessment score from the score given by the external observer for each CBS item. The anosognosia score ranges from 0 to 3 for each item and 0 to 30 in total. Higher scores represent more severe neglect anosognosia.
Lesion site-cortical involvement
Time frame: Within the first week of admission to the inpatient rehabilitation clinic
A semi-quantitative lesion analysis will be conducted on brain magnetic resonance or computed tomography imaging records. Lesions will be scored as 1 or 0, respectively, as those with and without cortical involvement. The frequency of lesions with cortical involvement will be determined.
Lesion site-regions of interest
Time frame: Within the first week of admission to the inpatient rehabilitation clinic
A semi-quantitative lesion analysis will be conducted on brain magnetic resonance or computed tomography imaging records. Lesions will be scored as 1 and 0, respectively, with and without the involvement of each region of interest (ROI). Seven ROIs have been identified: frontal, parietal, temporal, occipital, insula, basal ganglia, and thalamus. The frequencies will be determined for each ROI involvement. The frequency of lesions involving multiple ROIs will also be noted.
Lesion pervasiveness
Time frame: Within the first week of admission to the inpatient rehabilitation clinic
A semi-quantitative lesion analysis will be conducted on brain magnetic resonance or computed tomography imaging records. The total scores of ROIs involved will define the lesion pervasiveness score. It will range from 0 to 7, with a higher score representing a more pervasive lesion.
1 secondary outcome
Turkish version of the Mini-Mental State Examination (MMSE)
Time frame: Within the first week of admission to the inpatient rehabilitation clinic
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 22 Feb 2023.
- Background: PubMed 32927461Langer KG, Bogousslavsky J. The Merging Tracks of Anosognosia and Neglect. Eur Neurol. 2020;83(4):438-446. doi: 10.1159/000510397. Epub 2020 Sep 14.
- Background: PubMed 17022776Jehkonen M, Laihosalo M, Kettunen J. Anosognosia after stroke: assessment, occurrence, subtypes and impact on functional outcome reviewed. Acta Neurol Scand. 2006 Nov;114(5):293-306. doi: 10.1111/j.1600-0404.2006.00723.x.
- Background: PubMed 25023619Heilman KM. Possible mechanisms of anosognosia of hemiplegia. Cortex. 2014 Dec;61:30-42. doi: 10.1016/j.cortex.2014.06.007. Epub 2014 Jun 19.
- Background: PubMed 22627992Vossel S, Weiss PH, Eschenbeck P, Saliger J, Karbe H, Fink GR. The neural basis of anosognosia for spatial neglect after stroke. Stroke. 2012 Jul;43(7):1954-6. doi: 10.1161/STROKEAHA.112.657288. Epub 2012 May 24.
- Background: PubMed 25676676Rousseaux M, Allart E, Bernati T, Saj A. Anatomical and psychometric relationships of behavioral neglect in daily living. Neuropsychologia. 2015 Apr;70:64-70. doi: 10.1016/j.neuropsychologia.2015.02.011. Epub 2015 Feb 10.
- Background: PubMed 20512380Karnath HO, Baier B. Right insula for our sense of limb ownership and self-awareness of actions. Brain Struct Funct. 2010 Jun;214(5-6):411-7. doi: 10.1007/s00429-010-0250-4. Epub 2010 May 29.
- Background: PubMed 30013928Laporta-Hoyos O, Fiori S, Pannek K, Ballester-Plane J, Leiva D, Reid LB, Pagnozzi AM, Vazquez E, Delgado I, Macaya A, Pueyo R, Boyd RN. Brain lesion scores obtained using a simple semi-quantitative scale from MR imaging are associated with motor function, communication and cognition in dyskinetic cerebral palsy. Neuroimage Clin. 2018 Jun 14;19:892-900. doi: 10.1016/j.nicl.2018.06.015. eCollection 2018.
- Background: PubMed 15156794Pia L, Neppi-Modona M, Ricci R, Berti A. The anatomy of anosognosia for hemiplegia: a meta-analysis. Cortex. 2004 Apr;40(2):367-77. doi: 10.1016/s0010-9452(08)70131-x.
- Individual participant dataSharing planned: No
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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.
Gülçin Kaymak Karataş, MD principal investigator
Gazi University Faculty of Medicine
Levent Karataş, MD principal investigator
Gazi University Faculty of Medicine
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 Anosognosia and Neglect, Hemispatial, run by Gazi University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 22 Feb 2023. 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 Turkey (Türkiye). 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?
Neglect Score on Catherine Bergego Scale (CBS) (time frame: Within the first week of admission to the inpatient rehabilitation clinic). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05654350, which also lists 8 linked publications.
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 22 Feb 2023.