Cognitive-functional Evaluation of Anosognosia

NCT03712839 | Completed

• 1 other identifier: PSI2016-80331-P
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Anosognosia; Brain Damage

Keywords

Activities of Daily Living (ADL); Executive Deficit; Monitoring; Self Awareness

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (10)

• Mini-Mental State Examination

  10 minutes

• Line cancellation test

  3-5 minutes

• Line bisection test

  3-5 minutes

• Key search test

  2-4 minutes

• INECO Frontal Screening

  6-10 minutes

Study Arms (3)

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

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

Control group

Healthy participants matched in age, gender and educational level with the others two groups.

Other: Cognitive-functional evaluation

Interventions

Cognitive-functional evaluation OTHER

The participants will be evaluated with a set of tools within the context of meaningful ADL.

Acquired Brain Injury group with anosognosia; Acquired Brain Injury group without anosognosia; Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• María Rodríguez Bailón: lead
• Universidad de Granada: collaborator

Related Publications (12)

• 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.

  PMID: 1202204 BACKGROUND

• 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.

  PMID: 12164673 BACKGROUND

• 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.

  PMID: 9753533 BACKGROUND

• 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.

  PMID: 15849156 BACKGROUND

• 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.

  PMID: 23270921 BACKGROUND

• 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.

  PMID: 25805061 BACKGROUND

• 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.

  PMID: 11997493 BACKGROUND

• 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.

  PMID: 7555008 BACKGROUND

• 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.

  PMID: 8800616 BACKGROUND

• 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.

  PMID: 19635178 BACKGROUND

• Toglia J, Kirk U. Understanding awareness deficits following brain injury. NeuroRehabilitation. 2000;15(1):57-70.

  PMID: 11455082 BACKGROUND

• 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.

  PMID: 33109646 DERIVED

MeSH Terms

Conditions

Agnosia; Brain Injuries

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• María Jesús Funes-Molina, Professor

  Facultad de Psicología (Departamento de Psicología Experimental) - Campus de Cartuja s/n, Granada, 18071

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2018
• First Posted: October 19, 2018
• Study Start: October 18, 2016
• Primary Completion: March 1, 2020
• Study Completion: June 1, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05