NCT05145855

Brief Summary

Anosognosia for hemispatial neglect is an intriguing phenomenon characterized by decreased awareness of spatial deficits, common in patients with right hemisphere stroke. However, it has not been examined as extensively as anosognosia for hemiplegia. In this study, we aim to investigate the relationship between the decrease in anosognosia for neglect and the improvement of spatial deficits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

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 11, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

November 29, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

16 days

First QC Date

November 11, 2021

Last Update Submit

November 29, 2022

Conditions

Keywords

AnosognosiaHemispatial neglectCatherine Bergego ScaleCognitive rehabilitationBrain injury

Outcome Measures

Primary Outcomes (4)

  • Catherine Bergego Scale score before rehabilitation

    Catherine Bergego Scale score, which was assigned before rehabilitation 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, collide when moving, spatial orientation and, finding belongings. For each item, a 4-point scale ranging from 0 (no ignore) to 3 (severe ignore) is used. The sum of scores of all items ranges from zero to 30. Higher scores represent more severe spatial neglect behavior.

    Baseline (before rehabilitation)

  • Score of anosognosia for neglect before rehabilitation

    Anosognosia score, which was calculated based on the Catherine Bergego Scale before rehabilitation, will be obtained. Catherine Bergego Scale is a parallel test that can be applied to patients by themselves or by observers. The score of anosognosia for HN will be calculated by subtracting the patient's self-assessment score from the rehabilitation nurse's assessment score. Higher scores show more severe anosognosia for hemispatial neglect.

    Baseline (before rehabilitation)

  • Catherine Bergego Scale score after rehabilitation

    Catherine Bergego Scale score, which was assigned after rehabilitation 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, collide when moving, spatial orientation and, finding belongings. For each item, a 4-point scale ranging from 0 (no ignore) to 3 (severe ignore) is used. The sum of scores of all items ranges from zero to 30. Higher scores represent more severe spatial neglect behavior.

    Immediately after the rehabilitation

  • Score of anosognosia for neglect after rehabilitation

    Anosognosia score, which was calculated based on the Catherine Bergego Scale after rehabilitation, will be obtained. Catherine Bergego Scale is a parallel test that can be applied to patients by themselves or by observers. The score of anosognosia for HN will be calculated by subtracting the patient's self-assessment score from the rehabilitation nurse's assessment score. Higher scores show more severe anosognosia for hemispatial neglect.

    Immediately after the rehabilitation

Secondary Outcomes (8)

  • Prevalence of the extinction on the visual double simultaneous stimulation test

    Baseline (before rehabilitation)

  • Prevalence of the extinction on the auditory double simultaneous stimulation test

    Baseline (before rehabilitation)

  • Prevalence of the extinction on the tactile double simultaneous stimulation test

    Baseline (before rehabilitation)

  • Functional Ambulation Classification

    Baseline (before rehabilitation)

  • Functional Independence Measurement

    Baseline (before rehabilitation)

  • +3 more secondary outcomes

Study Arms (2)

Anosognosia-positive group

Patients will be included in the anosognosia-positive group if they achieved at least one positive anosognosia score before rehabilitation. The anosognosia score for HN will be calculated by subtracting the patient's self-evaluation score from the score assigned by the rehabilitation nurse using the parallel Catherine Bergego Scale.

Other: Patient-tailored multimodal neglect rehabilitation

Anosognosia-negative group

Patients will be included in the anosognosia-negative group if they achieved zero or negative anosognosia score before rehabilitation.

Other: Patient-tailored multimodal neglect rehabilitation

Interventions

Patient-tailored neglect rehabilitation program which comprises 30-45 minutes of sessions, five times per week includes a combination of reading, copying, and representational drawing tasks with visual or verbal cueing, visual scanning, mirror therapy, and allocation of attention to the neglected side using multimodal stimulus in daily activities.

Anosognosia-negative groupAnosognosia-positive group

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 hemisphere injury who have hemispatial neglect.

You may qualify if:

  • Being older than 18 years of age
  • Having subacute or chronic right hemisphere injury
  • Having left-sided hemispatial neglect based on Catherine Bergego Scale assessment.

You may not qualify if:

  • Acute cerebral injury (within the first two weeks of disease),
  • Bilateral cerebral lesions
  • Other neurological and psychiatric disorders that prevent evaluation of HN (e.g., severe cognitive or primer visual impairment)

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 (5)

  • 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
  • Ronchi R, Bolognini N, Gallucci M, Chiapella L, Algeri L, Spada MS, Vallar G. (Un)awareness of unilateral spatial neglect: a quantitative evaluation of performance in visuo-spatial tasks. Cortex. 2014 Dec;61:167-82. doi: 10.1016/j.cortex.2014.10.004.

    PMID: 25481474BACKGROUND
  • Chen P, Toglia J. Online and offline awareness deficits: Anosognosia for spatial neglect. Rehabil Psychol. 2019 Feb;64(1):50-64. doi: 10.1037/rep0000207. Epub 2018 Apr 12.

    PMID: 29648845BACKGROUND
  • Toglia J, Chen P. Spatial exploration strategy training for spatial neglect: A pilot study. Neuropsychol Rehabil. 2022 Jun;32(5):792-813. doi: 10.1080/09602011.2020.1790394. Epub 2020 Jul 20.

    PMID: 32684100BACKGROUND
  • Karatas L, Utkan Karasu A, Karatas GK. The effect of offline anosognosia for hemispatial neglect on neglect rehabilitation in patients with subacute and chronic right hemispheric brain injury. A retrospective cohort study. Neuropsychol Rehabil. 2024 Apr;34(3):453-468. doi: 10.1080/09602011.2023.2202862. Epub 2023 Apr 19.

MeSH Terms

Conditions

Perceptual DisordersHemiplegiaAgnosiaBrain Injuries

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsParalysisBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Gülçin Kaymak Karataş, MD

    Gazi University Faculty of Medicine

    PRINCIPAL INVESTIGATOR
  • Levent Karataş, MD

    Gazi University Faculty of Medicine

    PRINCIPAL INVESTIGATOR
  • Ayça Utkan Karasu, MD

    Gazi University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Principal Investigator

Study Record Dates

First Submitted

November 11, 2021

First Posted

December 6, 2021

Study Start

November 29, 2021

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

December 2, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations