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Clinical Trials/NCT03712839
NCT03712839
Completed
Not Applicable

Cognitive and Cerebral Mechanisms of Anosognosia in Patients With Acquired Brain Damage: New Evaluation Strategies Based on Daily Tasks

María Rodríguez Bailón0 sites48 target enrollmentOctober 18, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anosognosia
Sponsor
María Rodríguez Bailón
Enrollment
48
Primary Endpoint
The awareness ADL
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Acquired brain damage patients usually show severe cognitive deficit that alter their performance on every day life activities. Some of them suffer anosognosia and they are not aware of their own limitations. This situation increases disability by producing a large number of unsafe behaviours, caregivers burn-out and impede rehabilitation by affecting patients desire to follow treatment instructions. From disciplines like Neuropsychology, Cognitive Neuroscience or Occupational Therapy, it is considered a crucial issue to investigate the cognitive and neural mechanisms responsible of anosognosia, as well as to increase our knowledge about the most efficient treatments to deal with this phenomenon. The main general objective of this project is to generate and validate a detailed cognitive assessment protocol within the context of ADL to evaluate the different cognitive components of consciousness proposed on the Toglia and Kirk´s model: 1) Offline componente: metacognitive knowledge and 2) Online component: emergent awareness, self-regulation, anticipatory awareness, self-evaluation and updating processes).

Detailed Description

The proposed protocol is composed by two ecological tools: The Cog-Awareness ADL Scale (ADL scale of metacognitive knowledge) and the Basic and Instrumental ADL performance based test (Awareness ADL), to identify the presence of cognitive deficits and anosognosia in patients with ABI always within the context of everyday life activities. One first specific aim is to test the convergent validity of the two proposed ecological tools with other traditional and validated measures usually used to assess similar cognitive processes and components of self-awareness. The second specific objective is to investigate the external validity of the ecological tools, by testing whether they are able to discriminate between acquired brain damage patients with and without anosognosia and a group of neurologically healthy participants on every component. After conducting a literature review of the subject we found that this would be the first protocol developed to identify all these components in the same study.

Registry
clinicaltrials.gov
Start Date
October 18, 2016
End Date
June 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
María Rodríguez Bailón
Responsible Party
Sponsor Investigator
Principal Investigator

María Rodríguez Bailón

Professor

University of Malaga

Eligibility Criteria

Inclusion Criteria

  • Presence of an acquired brain damage objectively observed with medical reports.
  • Cognitive deficits relative to executive functions and/or memory evaluated by the team of professionals who recruit participants in the hospital.

Exclusion Criteria

  • Presence of a serious visuoperceptual deficit that makes it difficult to complete the ADL tasks, evaluated by the team of professionals who recruit participants in the hospital.
  • Presence of an understanding deficit (aphasia) evaluated by the team of professionals who recruit participants in the hospital.
  • Presence of spatial neglect evaluated with line cancellation and line bisection tests.
  • Presence of motor deficits in both upper limbs that impedes to complete the ADL tasks.
  • Total score in MMSE\<18

Outcomes

Primary Outcomes

The awareness ADL

Time Frame: 30-45 minutes

Participants will be asked to do activities of daily living such as preparing a breakfast or dressing in which measures that evaluate components of anosognosia will be used. In the tasks of ADL conflict situations (and standardized solutions previously defined) and distractor objects will be presented. The total errors committed will be analyzed, as well as those committed only by conflict situations and distractor objects. The percentage of errors detected and corrected errors will be calculated. In addition, anticipatory awareness, self-evaluation and updating processes will be examined.

The Cog-Awareness ADL Scale

Time Frame: 10-15 minutes

For the aim of this study, the Cog-Awareness ADL Scale, will have two versions, one to be administered to a direct caregiver and the other to the patient to observe the discrepancy index in relation to functionality-cognition. This tool allow to evaluate eight key cognitive abilities-task: manipulation difficulties, action schema, distraction, substitution, repetition, error detection, problem solving and task self-initiation in the two basic ADL and in the two instrumental ADL (BADL and IADL, respectively) (34 items). Both patients and caregivers must answer how often the patients present this cognitive-functional error in each of the 4 ADLs: 1: never, 2: sometimes, 3: quite often and 4: always. Two indices are calculated, one for BADL and one for IADL, adding all the scores of the two activities of each category among the number of activities answered. Lower punctuation is interpreted with worse results. There are 3 items that your scores should be reversed.

Secondary Outcomes

  • Rey Auditory Verbal Learning Test(10-15 minutes)
  • Verbal Fluency Test(5 minutes)
  • Mini-Mental State Examination(10 minutes)
  • Line cancellation test(3-5 minutes)
  • INECO Frontal Screening(6-10 minutes)
  • Color trail making(6 minutes)
  • Key search test(2-4 minutes)
  • Line bisection test(3-5 minutes)
  • Patient Competency Rating Scale(6-10 minutes)
  • Weekly Calendar Planning Activity (WCPA)(20 minutes)

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