Clinical trial NCT03712839: Cognitive-functional Evaluation of Anosognosia
Official title: Cognitive and Cerebral Mechanisms of Anosognosia in Patients With Acquired Brain Damage: New Evaluation Strategies Based on Daily Tasks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anosognosia
Brain Damage
Keywords: Activities of Daily Living (ADL)
Executive Deficit
Monitoring
Self Awareness
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Universidad de Granada
First posted: 2018-10-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acquired brain damage patients will be recruited on the collaborating hospitals and on different acquired brain damage organisations. Both, patients and control subjects, will be recruited from Málaga and Granada.

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.

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

Primary outcomes:
measure: The awareness ADL
timeFrame: 30-45 minutes
measure: The Cog-Awareness ADL Scale
timeFrame: 10-15 minutes
Secondary outcomes:
measure: Mini-Mental State Examination
timeFrame: 10 minutes
measure: Line cancellation test
timeFrame: 3-5 minutes
measure: Line bisection test
timeFrame: 3-5 minutes
measure: Key search test
timeFrame: 2-4 minutes
measure: INECO Frontal Screening
timeFrame: 6-10 minutes
measure: Color trail making
timeFrame: 6 minutes
measure: Rey Auditory Verbal Learning Test
timeFrame: 10-15 minutes
measure: Patient Competency Rating Scale
timeFrame: 6-10 minutes
measure: Verbal Fluency Test
timeFrame: 5 minutes
measure: Weekly Calendar Planning Activity (WCPA)
timeFrame: 20 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Facultad de Psicología (Departamento de Psicología Experimental) - Campus de Cartuja s/n, Granada, 18071
name: María Jesús Funes-Molina, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Rodriguez-Bailon M, Montoro-Membila N, Garcia-Moran T, Arnedo-Montoro ML, Funes Molina MJ. Preliminary cognitive scale of basic and instrumental activities of daily living for dementia and mild cognitive impairment. J Clin Exp Neuropsychol. 2015;37(4):339-53. doi: 10.1080/13803395.2015.1013022. Epub 2015 Mar 25.
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citation: Sirigu A, Zalla T, Pillon B, Grafman J, Agid Y, Dubois B. Encoding of sequence and boundaries of scripts following prefrontal lesions. Cortex. 1996 Jun;32(2):297-310. doi: 10.1016/s0010-9452(96)80052-9.
citation: Torralva T, Roca M, Gleichgerrcht E, Lopez P, Manes F. INECO Frontal Screening (IFS): a brief, sensitive, and specific tool to assess executive functions in dementia. J Int Neuropsychol Soc. 2009 Sep;15(5):777-86. doi: 10.1017/S1355617709990415. Epub 2009 Jul 28.
citation: Toglia J, Kirk U. Understanding awareness deficits following brain injury. NeuroRehabilitation. 2000;15(1):57-70.
citation: Merchan-Baeza JA, Rodriguez-Bailon M, Ricchetti G, Navarro-Egido A, Funes MJ. Awareness of cognitive abilities in the execution of activities of daily living after acquired brain injury: an evaluation protocol. BMJ Open. 2020 Oct 26;10(10):e037542. doi: 10.1136/bmjopen-2020-037542.