Cognitive-functional Evaluation of Anosognosia

Brain Damage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712839
• Other study ID #: PSI2016-80331-P
• Status: Completed
• Start date: October 18, 2016
• Est. completion date: June 2022

Study information

• Verified date: May 2023
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2022
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anosognosia
• Brain Damage
• Brain Injuries

Intervention

Other:
• Cognitive-functional evaluation
The participants will be evaluated with a set of tools within the context of meaningful ADL.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
María Rodríguez Bailón	Universidad de Granada

References & Publications (11)

Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available. — View Citation

Forde EM, Humphreys GW, Remoundou M. Disordered knowledge of action order in action disorganisation syndrome. Neurocase. 2004 Feb;10(1):19-28. doi: 10.1080/13554790490960459. — View Citation

Forde EM, Humphreys GW. Dissociations in routine behaviour across patients and everyday tasks. Neurocase. 2002;8(1-2):151-67. doi: 10.1093/neucas/8.1.151. — View Citation

Giovannetti T, Libon DJ, Hart T. Awareness of naturalistic action errors in dementia. J Int Neuropsychol Soc. 2002 Jul;8(5):633-44. doi: 10.1017/s135561770280131x. — View Citation

Prigatano GP, Bruna O, Mataro M, Munoz JM, Fernandez S, Junque C. Initial disturbances of consciousness and resultant impaired awareness in Spanish patients with traumatic brain injury. J Head Trauma Rehabil. 1998 Oct;13(5):29-38. doi: 10.1097/00001199-199810000-00005. — View 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. — View Citation

Schmidt J, Fleming J, Ownsworth T, Lannin NA. Video feedback on functional task performance improves self-awareness after traumatic brain injury: a randomized controlled trial. Neurorehabil Neural Repair. 2013 May;27(4):316-24. doi: 10.1177/1545968312469838. Epub 2012 Dec 27. — View 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. — View Citation

Sirigu A, Zalla T, Pillon B, Grafman J, Agid Y, Dubois B. Selective impairments in managerial knowledge following pre-frontal cortex damage. Cortex. 1995 Jun;31(2):301-16. doi: 10.1016/s0010-9452(13)80364-4. — View Citation

Toglia J, Kirk U. Understanding awareness deficits following brain injury. NeuroRehabilitation. 2000;15(1):57-70. — View 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. Erratum In: J Int Neuropsychol Soc. 2010 Sep;16(5):737. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The awareness ADL	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.	30-45 minutes
Primary	The Cog-Awareness ADL Scale	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.	10-15 minutes
Secondary	Mini-Mental State Examination	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.	10 minutes
Secondary	Line cancellation test	General cognitive status. In the LCT the patient is asked to cross out all the lines (or particular items) on a sheet.	3-5 minutes
Secondary	Line bisection test	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.	3-5 minutes
Secondary	Key search test	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.	2-4 minutes
Secondary	INECO Frontal Screening	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.	6-10 minutes
Secondary	Color trail making	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.	6 minutes
Secondary	Rey Auditory Verbal Learning Test	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.	10-15 minutes
Secondary	Patient Competency Rating Scale	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)	6-10 minutes
Secondary	Verbal Fluency Test	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.	5 minutes
Secondary	Weekly Calendar Planning Activity (WCPA)	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.	20 minutes