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Cognitive-functional Evaluation of Anosognosia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03712839
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2018
Last Update Posted : April 8, 2020
Universidad de Granada
Information provided by (Responsible Party):
María Rodríguez Bailón, University of Malaga

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).

Condition or disease Intervention/treatment
Anosognosia Brain Damage Other: Cognitive-functional evaluation

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.

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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Cognitive and Cerebral Mechanisms of Anosognosia in Patients With Acquired Brain Damage: New Evaluation Strategies Based on Daily Tasks
Actual Study Start Date : October 18, 2016
Actual Primary Completion Date : March 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Acquired Brain Injury group with anosognosia
People with presence of an acquired brain damage and cognitive deficits relative to executive functions and memory. To determine the presence of anosognosia, patients must present an overestimation value of their capacities greater than 5 (>5) in the discrepancy index on the Patient Competency Rating Scale (PCRS) (Prigatano et al., 1998).
Other: Cognitive-functional evaluation
The participants will be evaluated with a set of tools within the context of meaningful ADL.

Acquired Brain Injury group without anosognosia
People with presence of an acquired brain damage and cognitive deficits relative to executive functions and memory. These patients must present a score of < 5 on the PCRS Scale.
Other: Cognitive-functional evaluation
The participants will be evaluated with a set of tools within the context of meaningful ADL.

Control group
Healthy participants matched in age, gender and educational level with the others two groups.
Other: Cognitive-functional evaluation
The participants will be evaluated with a set of tools within the context of meaningful ADL.

Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Mini-Mental State Examination [ Time Frame: 10 minutes ]
    General cognitive status. MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment.

  2. Line cancellation test [ Time Frame: 3-5 minutes ]
    General cognitive status. In the LCT the patient is asked to cross out all the lines (or particular items) on a sheet.

  3. Line bisection test [ Time Frame: 3-5 minutes ]
    General cognitive status. The LBT is a quick measure to detect the presence of unilateral spatial neglect (USN). To complete the test, one must place a mark with a pencil through the center of a series of horizontal lines. Usually, a displacement of the bisection mark towards the side of the brain lesion is interpreted as a symptom of neglect.

  4. Key search test [ Time Frame: 2-4 minutes ]
    Executive functions. Participants are required to search for an imaginary key they have lost on a field (a square on a piece of paper). By drawing their search route, an indication of search strategy and planning ability can be deduced.

  5. INECO Frontal Screening [ Time Frame: 6-10 minutes ]
    Executive functions. This screening test was designed to provide health professionals with a sensitive and specific executive screening test to determine frontal dysfunction in patients with dementia.

  6. Color trail making [ Time Frame: 6 minutes ]
    Executive functions. Numbered circles are printed with vivid pink or yellow backgrounds that are perceptible to colorblind individuals. For Part 1, the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2, the respondent rapidly connects numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.

  7. Rey Auditory Verbal Learning Test [ Time Frame: 10-15 minutes ]
    Semantic and episodic memory. The RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval.

  8. Patient Competency Rating Scale [ Time Frame: 6-10 minutes ]

    Metacognitive knowledge. The primary purpose of the PCRS is to evaluate self-awareness (the ability to appraise one's current strengths and weaknesses) following traumatic brain injury. The PCRS is a 30-item self-report instrument which asks the subject to use a 5-point Likert scale to rate his or her degree of difficulty in a variety of tasks and functions. The subject's responses are compared to those of a significant other (a relative or therapist) who rates the subject on the identical items. Impaired self-awareness may be inferred from discrepancies between the two ratings, such that the subject overestimates his/ her abilities compared to the other informant. Awareness of deficit may also be examined separately for activities of daily living, behavioral and emotional function, cognitive abilities, and physical function. Range Discrepancy index range 1-150.

    Mean healthy subjects: 144 range (120-150) and relatives 145 (range 134-150) (Prigatano, 1998)

  9. Verbal Fluency Test [ Time Frame: 5 minutes ]
    In this test the participants have to produce as many words as possible from a category in a 60 seconds. This category is semantic (animals) and phonemic, including words beginning with F, A and S.

  10. Weekly Calendar Planning Activity (WCPA) [ Time Frame: 20 minutes ]
    This is a performance based test that measures different executive functions, among which are: planning, problem solving, inhibition of non-relevant information and maintenance and monitoring of rules. In its short version, it is based on asking the patient to schedule 10 appointments (that appear in random order) during a 1 week span. Some appointments are incompatible with others, so the patient has to take them into account to plan correctly. In addition, the patient is asked to comply with 5 rules which are informed at the beginning of the test and are kept in view throughout the task. The test provides different variables for its analysis, as well as the successes when planning, such as the types of mistakes made, the ability to detect them, the time, the rules followed or the strategies used.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03712839

Sponsors and Collaborators
María Rodríguez Bailón
Universidad de Granada
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Principal Investigator: María Jesús Funes-Molina, Professor Facultad de Psicología (Departamento de Psicología Experimental) - Campus de Cartuja s/n, Granada, 18071

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Responsible Party: María Rodríguez Bailón, Professor, University of Malaga Identifier: NCT03712839    
Other Study ID Numbers: PSI2016-80331-P
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by María Rodríguez Bailón, University of Malaga:
Activities of Daily Living (ADL)
Executive Deficit
Self Awareness
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms