Stroke Clinical Trial
Official title:
The Relationship Between Lesion Site And Neglect Anosognosia in Right Hemispheric Stroke Patients With Left Hemispatial Neglect
Verified date | December 2022 |
Source | Gazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | January 21, 2023 |
Est. primary completion date | January 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Being older than 18 years of age - Having a subacute or chronic right hemispheric supratentorial stroke - Having left hemispatial neglect Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Gazi University Hospital, Department of Physical Medicine and Rehabilitation | Ankara |
Lead Sponsor | Collaborator |
---|---|
Gazi University |
Turkey,
Heilman 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. — View Citation
Jehkonen 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. — View Citation
Karnath 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. — View Citation
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. — View Citation
Laporta-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. — View Citation
Pia 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. — View Citation
Rousseaux 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. — View Citation
Vossel 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Within the first week of admission to the inpatient rehabilitation clinic | |
Primary | 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. | Within the first week of admission to the inpatient rehabilitation clinic | |
Primary | 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. | Within the first week of admission to the inpatient rehabilitation clinic | |
Primary | 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. | Within the first week of admission to the inpatient rehabilitation clinic | |
Primary | 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. | Within the first week of admission to the inpatient rehabilitation clinic | |
Secondary | 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. | Within the first week of admission to the inpatient rehabilitation clinic |
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