Clinical Trials Directory

Trials / Completed

CompletedNCT03712839

Cognitive-functional Evaluation of Anosognosia

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

Status
Completed
Phase
Study type
Observational
Enrollment
48 (actual)
Sponsor
María Rodríguez Bailón · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERCognitive-functional evaluationThe participants will be evaluated with a set of tools within the context of meaningful ADL.

Timeline

Start date
2016-10-18
Primary completion
2020-03-01
Completion
2022-06-01
First posted
2018-10-19
Last updated
2023-05-10

Source: ClinicalTrials.gov record NCT03712839. Inclusion in this directory is not an endorsement.