AnosognosiaNCT03712839

Cognitive-functional Evaluation of Anosognosia

An observational study of Anosognosia and Brain Damage, run by María Rodríguez Bailón.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Anosognosia, Brain Damage
What is being tested?: Cognitive-functional evaluation
How many people: 48 participants
Where: No sites listed yet
Study dates: 18 Oct 2016to Jun 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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

About this study

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

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).

Read the 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.

Conditions: Anosognosia, Brain Damage
Being tested: Cognitive-functional evaluation
Keywords: Activities of Daily Living (ADL), Executive Deficit, Monitoring, Self Awareness
Medical subject headings: Agnosia, Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03712839
Study group	Role	What they receive
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). Receives: 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. Receives: Other: Cognitive-functional evaluation
Control group		Healthy participants matched in age, gender and educational level with the others two groups. Receives: Other: Cognitive-functional evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 10-15 minutes

Secondary outcomes (10)

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.
Measured: 10 minutes
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.
Measured: 3-5 minutes
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.
Measured: 3-5 minutes
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.
Measured: 2-4 minutes
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.
Measured: 6-10 minutes
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.
Measured: 6 minutes
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.
Measured: 10-15 minutes
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)
Measured: 6-10 minutes
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.
Measured: 5 minutes
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.
Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Oct 2016Jun 2022

First posted19 Oct 2018
Study start18 Oct 2016
Primary completionMar 2020
Study completionJun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for AnosognosiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03712839
Sponsor's protocol ID: PSI2016-80331-P
Status last verified: May 2023
First submitted: 8 Sep 2018
Last updated: 10 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 1202204
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.
PubMed 12164673
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.
PubMed 9753533
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.
PubMed 15849156
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.
PubMed 23270921
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.
PubMed 25805061
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.
PubMed 11997493
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.
PubMed 7555008
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.
PubMed 8800616
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.
PubMed 19635178
Toglia J, Kirk U. Understanding awareness deficits following brain injury. NeuroRehabilitation. 2000;15(1):57-70.
PubMed 11455082
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.
PubMed 33109646

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Psychotic Disorders, Family Members
RecruitingObservational study
Study of Repetitive Behaviors in Alzheimer's Disease
Alzheimer Disease, Anterograde Amnesia
Not yet recruitingObservational study
Mild Cognitive Impairment and Psychopathology
Mild Cognitive Impairment (MCI)
Not yet recruiting
Improving Awareness for Spatial Neglect With tDCS
Stroke, Anosognosia
Not yet recruitingObservational study
Development of a Novel Screening Tool for Anosognosia After Stroke.
Anosognosia, Stroke

All Anosognosia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cognitive and Cerebral Mechanisms of Anosognosia in Patients With Acquired Brain Damage: New Evaluation Strategies Based on Daily Tasks
ClinicalTrials.gov ID: NCT03712839
Acronym / sponsor ID: PSI2016-80331-P
Conditions: Anosognosia, Brain Damage
Keywords: Activities of Daily Living (ADL), Executive Deficit, Monitoring, Self Awareness
Study type: Observational
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: María Rodríguez BailónUniversity, hospital or other
Collaborators: Universidad de Granada
Study start: 18 Oct 2016 (actual)
Primary completion: Mar 2020 (actual)
Study completion: Jun 2022 (actual)
First posted: 19 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
Acquired Brain Injury group with anosognosia	–	Other: Cognitive-functional evaluationPeople 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).
Acquired Brain Injury group without anosognosia	–	Other: Cognitive-functional evaluationPeople 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.
Control group	–	Other: Cognitive-functional evaluationHealthy participants matched in age, gender and educational level with the others two groups.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive-functional evaluationThe participants will be evaluated with a set of tools within the context of meaningful ADL.	Other	Acquired Brain Injury group with anosognosia, Acquired Brain Injury group without anosognosia, Control group

Primary outcome

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.
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.

10 secondary outcomes

Mini-Mental State Examination
Time frame: 10 minutes
Line cancellation test
Time frame: 3-5 minutes
Line bisection test
Time frame: 3-5 minutes
Key search test
Time frame: 2-4 minutes
INECO Frontal Screening
Time frame: 6-10 minutes
Color trail making
Time frame: 6 minutes
Rey Auditory Verbal Learning Test
Time frame: 10-15 minutes
Patient Competency Rating Scale
Time frame: 6-10 minutes
Verbal Fluency Test
Time frame: 5 minutes
Weekly Calendar Planning Activity (WCPA)
Time frame: 20 minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
Background: PubMed 1202204Folstein 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.
Background: PubMed 12164673Giovannetti 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.
Background: PubMed 9753533Prigatano 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.
Background: PubMed 15849156Forde 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.
Background: PubMed 23270921Schmidt 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.
Background: PubMed 25805061Rodriguez-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.
Background: PubMed 11997493Forde 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.
Background: PubMed 7555008Sirigu 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.
Background: PubMed 8800616Sirigu 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.
Background: PubMed 19635178Torralva 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.
Background: PubMed 11455082Toglia J, Kirk U. Understanding awareness deficits following brain injury. NeuroRehabilitation. 2000;15(1):57-70.
Derived from this study: PubMed 33109646Merchan-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.

Related trials for Anosognosia

Recruiting
Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Psychotic Disorders, Family Members
RecruitingObservational study
Study of Repetitive Behaviors in Alzheimer's Disease
Alzheimer Disease, Anterograde Amnesia
Not yet recruitingObservational study
Mild Cognitive Impairment and Psychopathology
Mild Cognitive Impairment (MCI)
Not yet recruiting
Improving Awareness for Spatial Neglect With tDCS
Stroke, Anosognosia
Not yet recruitingObservational study
Development of a Novel Screening Tool for Anosognosia After Stroke.
Anosognosia, Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

María Jesús Funes-Molina, Professor principal investigator

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

Questions about this trial

What is this clinical trial studying?

An observational study of Anosognosia and Brain Damage, run by María Rodríguez Bailón.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The awareness ADL (time frame: 30-45 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03712839, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.