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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 : February 26, 2019
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 and error commissions. 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 aim of the project is to create and validate a set of tools to isolate different components of Anosognosia, like error monitoring o autobiographical memory deficit that impede remembering committing those errors. These tasks will be designed within the context of significant everyday tasks to improve the ecological validity.

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

Detailed Description:

The main objective of this project is to generate a protocol to identify the presence of anosognosia in acquired brain damage, but also, identify profiles depending on the altered components. The analyzed components, based on Toglia and Kirk´s model, will be metacognitive knowledge (exists prior to a task or situation), and online awareness (activated within tasks and situations), composed of conceptualization and appraisal of the task and situation, self monitoring of current cognitive state and self evaluation.

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 : 100 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
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Experimental group
People with presence of an acquired brain damage and cognitive deficits relative to executive functions and memory. Both groups received the cognitive-functional evaluation.
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 experimental group. Both groups received the cognitive-functional evaluation.
Other: Cognitive-functional evaluation
The participants will be evaluated with a set of tools within the context of meaningful ADL.

Primary Outcome Measures :
  1. Direct execution tasks [ 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 dissociate components of anosognosia will be used. In the tasks of ADL traps will be presented (controlled error situations and standardized solutions previously defined), the types of errors will be codified, and a protocol for coding the level of monitoring of the errors that distinguishes at least 5 levels will also be created. Questions will be asked about subjective estimates of pre, post immediate and post long term execution, etc.

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. Rey-Osterrieth complex figure test [ Time Frame: 6 minutes ]
    General cognitive status. The ROCF is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by copying it freehand (recognition), and then drawing from memory (recall). Many different cognitive abilities are needed for a correct performance, and the test therefore permits the evaluation of different functions, such as visuospatial abilities, memory, attention, planning, working memory and (executive functions).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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 the various domains sampled by PCRS items. These include activities of daily living, behavioral and emotional function, cognitive abilities, and physical function.

  10. Cognitive Scale of the ADL [ Time Frame: 10-15 minutes ]
    This scale aims to measure the degree of impact that entails the cognitive alterations in the activities of daily life in patients with cognitive impairment of any etiology. It must be completed by a caregiver / relative who knows the execution of the patient or by a professional (in the case that patients are internal in an institution). In the first place, he is asked about the frequency and degree of assistance with which he did the activities before the hip fracture and currently (16 items). In the second part, the caregiver or professional will find a series of sentences that describe how the patient performs various aspects of tasks (34 items). You must cross out or circle with it, depending on how you do the activity described in the following way: 1: Never, 2: Sometimes, 3: Quite often and 4: Always.

  11. Reaction time from post error slowing [ Time Frame: 20 minutes ]
    Experimental computarized task of direct execution of cognitive control and monitoring.

  12. Accuracy measurements from post error increasement [ Time Frame: 20 minutes ]
    Experimental computarized task of direct execution of cognitive control and monitoring.

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 AVD´s 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 cognitive impairment evaluated with Mini-Mental State Examination (score of <24) .
  • Presence of motor deficits in both upper limbs that impedes to complete the AVD´s tasks.

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     History of Changes
Other Study ID Numbers: PSI2016-80331-P
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

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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