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NCT Number: NCT05654350

Lesion Site and Neglect Anosognosia in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University Hospital, Department of Physical Medicine and Rehabilitation

Ankara, 06560, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Turkish version of the Mini-Mental State Examination (MMSE)

    Time frame: Within the first week of admission to the inpatient rehabilitation clinic

    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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

The Relationship Between Lesion Site And Neglect Anosognosia in Right Hemispheric Stroke Patients With Left Hemispatial Neglect

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 16, 2022
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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