NCT05654350

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 16, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2023

Completed
Last Updated

February 22, 2023

Status Verified

December 1, 2022

Enrollment Period

1 month

First QC Date

November 29, 2022

Last Update Submit

February 21, 2023

Conditions

Keywords

Neglect anosognosiaStrokeHemispatial neglectSelf-awarenessAnosognosia

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

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

    Within the first week of admission to the inpatient rehabilitation clinic

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with subacute or chronic right hemispheric stroke with left hemispatial neglect

You may qualify if:

  • Being older than 18 years of age
  • Having a subacute or chronic right hemispheric supratentorial stroke
  • Having left hemispatial neglect

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Hospital, Department of Physical Medicine and Rehabilitation

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 32927461BACKGROUND
  • 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.

    PMID: 17022776BACKGROUND
  • 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.

    PMID: 25023619BACKGROUND
  • 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.

    PMID: 22627992BACKGROUND
  • 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.

    PMID: 25676676BACKGROUND
  • 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.

    PMID: 20512380BACKGROUND
  • 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.

    PMID: 30013928BACKGROUND
  • 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.

    PMID: 15156794BACKGROUND

MeSH Terms

Conditions

AgnosiaPerceptual DisordersStroke

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gülçin Kaymak Karataş, MD

    Gazi University Faculty of Medicine

    PRINCIPAL INVESTIGATOR
  • Levent Karataş, MD

    Gazi University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 16, 2022

Study Start

December 16, 2022

Primary Completion

January 20, 2023

Study Completion

January 21, 2023

Last Updated

February 22, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations