Efficacy of a Computerized Program of Cognitive Rehabilitation of Attention in People With Acquired Brain Injury (ABI): Pilot Study
Conditions: Brain Injuries
Sponsor: Ikerbasque - Basque Foundation for Science

[Escriba aquí] 
FFFF 
[Escriba aquí] 
 
 
 
Efficacy of a Computerized Program of 
Cognitive Rehabilitation of Attention in 
People with Acquired Brain Injury 
(ABI): Pilot Study 
 
 
 
 
 
ClinicalTrials.gov Identifier: NCT04214314 
Date: 02/12/2021 
 
 
 
 
 
 
 
 
 
 
 
 

[Escriba aquí] 
FFFF 
[Escriba aquí] 
 
 
STUDY PROTOCOL 
 
1.1 Screening tests 
Short attention test (BTA); (D. Schretlen, 1989). The test is used as a measure of 
divided attention. It can be used in people between 17 and 82 years, it is of individual 
application with an approximate duration of 10 minutes (D. Schretlen, Bobholz, & 
Brandt, 1996). 
Trail Making Test (TMT A-B); (Reitan & Wolfson, 1985). The test is used to 
evaluate attention, psychomotor speed, cognitive flexibility, visual search and 
executive functions (Fernandez, Marino, & Alderete, 2002). 
Test of Colors and Words (Stroop Test); (Stroop, 1935). It provides information on 
the inhibitory capacity of the subject and its resistance to stimulus interference 
(Stroop, 1935). 
Symbol and digit test (SDMT); (Smith, 2002). It is a test that involves the conversion 
of geometric designs into written and / or spoken numerical responses. The test is 
applied from 8 years to 78 and can be individually or collectively. Because the test 
consists of geometric figures and numbers, and these are universal symbols of 
written language, the SDMT test is relatively free of cultural and idiomatic factors 
and can be applied in different countries and languages (Smith, 2002). 
PASAT test is a measure of cognitive function that evaluates the speed and 
flexibility of the processing of auditory information, as well as the ability to calculate 
(Fischer, Jak, Kniker, Rudick, & Cutter, 2001). 
Bells Test. The Bells Test (Gauthier, Dehaut, & Joanette, 1989) is used to detect 
visual inattention in children and adults and it consists of a 21.5 × 28 cm sheet of 
paper on which seven lines of 35 distractor figures (e.g., bird, key, apple, mushroom, 
car) and five target figures (bells) are presented. The target figures are arranged so 
that five of each appears in seven equal columns on the page. A study of 576 healthy 
French subjects between the ages of 20 and 80 years conducted by Azouvi et al. 
(2002), considered a difference of 1 omission between the right and the left side as 
normal (95th percentile), and a difference of 5 as pathologic (5th percentile). Time 

[Escriba aquí] 
FFFF 
[Escriba aquí] 
 
for completion of the test was also analyzed, with a time longer than 183 subjects 
considered abnormal (normal mean time = 105 s). The group also considered the 
difference between right- and left-handers as not significant. 
Attention Test D2 is a cancellation task that evaluates the basic processes of selective 
attention and mental concentration. This instrument also reflects three components of 
attentional behavior: the speed or amount of work, the quality of work and the 
relationship between speed and accuracy of care (Brickenkamp, 2012). 
Minimental State Examination (MMSE), is a short and quantitative measurement 
that can be used to detect cognitive deficits, to assess its severity at a given time, to 
follow the course of cognitive changes over time and to evaluate the response to a 
treatment. Several investigations have shown that the MMSE is a reliable and valid 
instrument in different patient samples and the general population (Folstein, Folstein, 
McHugh, & Fanjiang, 1975). 
 
1.2 Study of cognitive functioning 
The following neuropsychological tests will be used to obtain information before the 
implementation of the intervention, after its implementation and at 6 months. The 
cognitive domains to evaluate will be: attention, memory, visuoperceptive skills, 
executive functions, processing speed and language. All the tests have scales for the 
Spanish population. Each of them is briefly described below: 
Hopkins Verbal Learning Test - Revised (HVLT-R; Benedict, Schretlen, Groninger, 
& Brandt, 1998). It is one of the most used tests to measure learning and verbal 
memory in the neuropsychological clinical evaluation. It consists of a list of 12 
words extracted from 3 different semantic categories (Benedict et al., 1998). 
Test of the complex figure of Rey (Rey, 2009). It is a very useful instrument to 
evaluate the perceptual organization and visual memory in people with brain 
damage, evaluate the ability to organize and plan strategies for problem solving, as 
well as the viso-constructive capacity (Cortés, Galindo, & Salvador, 1996). 
Modified test of classification of Wisconsin cards (M-WCST; Nelson, 1976; 
Schretlen, 2010). It is a variation of the Wisconsin Card Classification test created to 
assess abstract reasoning and the ability to adapt cognitive strategies to the changing 

[Escriba aquí] 
FFFF 
[Escriba aquí] 
 
environment. It is an individual application test for adults between 18 and 90 years 
and between the administration time and score add approximately 12 minutes 
(Nelson, 1976). 
Boston Denomination Test (BNT; Goodglass, Kaplan, & Barresi, 2005). The test 
consists of naming 60 sheets presented in order of difficulty. Its test-retest reliability 
coefficients are above 0.77 (del Toro et al., 2011; Pedraza, Sachs, Fernan, Rush, & 
Lucas, 2011) and has demonstrated good internal consistency with indexes greater 
than 0, 78 (Pedraza et al., 2011). 
Phonological and Semantic Verbal Fluency Test (Benton, Hamsher, & Sivan, 1994). 
These types of tests are highly sensitive to brain damage, so they are commonly 
administered to people with neurological damage (TBI, multiple sclerosis, 
dementias, etc.) (Henry & Crawford, 2004; Strauss, Sherman, & Spreen, 2006). 
These tests require the person to be flexible, organize the information and exercise 
inhibition when necessary. 
European Brain Injury Questionnaire (EBIQ; Sopena, Dewar, Nannery, Teasdale, & 
Wilson, 2007). It is a self-report that gives us a relative measure of the subjective 
experience of the cognitive, emotional and social difficulties experienced by people 
with ABI.  
 
1.3 Study of the attentional state in the patient's daily life 
Questionnaire of attention problems. This is a questionnaire prepared by the 
department's research team for this project with the objective of obtaining a measure 
of how attention problems affect the activities of the patient's daily life, said 
questionnaire consists of 7 questions, one of them multiple choice. 
Moss Attention Rating Scale (MARS;Whyte et al., 2008). It is made up of 22 items, 
through which an observational rating of the behaviors related to care is obtained. It 
is useful in evaluations of people with TBI (moderate - severe) (Whyte et al., 2008). 
 
 
 

[Escriba aquí] 
FFFF 
[Escriba aquí] 
 
1.4 Study of the emotional state of patients 
Several questionnaires will be used before and after the implementation of the 
program, as well as at 6 months to measure behavioral aspects, quality of life, 
satisfaction with life, patient functionality and subjective experience of social, 
emotional difficulties. and cognitive. 
Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001). This is a 
9-item questionnaire that evaluates the presence of major depressive disorder based 
on the criteria of the diagnostic and statistical manual of mental disorders (DSM-IV-
R). Difference between other depressive symptoms, positive depressive symptoms 
and negative depressive symptoms (Baader et al., 2012). 
Generalized Anxiety Disorders Scale (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 
2006). This is a 7-item scale that evaluates the presence of generalized anxiety 
disorder based on the criteria of the diagnostic and statistical manual of mental 
disorders (DSM-IV-R). The scale has been adapted to Spanish (García-Campayo et 
al., 2010). 
 
1.5 Quality of life study 
Quality of life scale (SF-36; Ware & Sherbourne, 1992) consists of 36 questions 
through which the quality of life related to physical and emotional health, the 
interference of physical and emotional problems in social life is evaluated, the degree 
of vitality, energy or fatigue and the general perception of health. 
Life Satisfaction Scale (SWLS; Diener, Emmons, Larsen, & Griffin, 1985). It is a 
global measure of satisfaction with life that consists of 5 items. Different studies 
have used this scale for the evaluation of life satisfaction of people with TBI 
(Corrigan, Bogner, Mysiw, Clinchot, & Fugate, 2001). 
 
1.6 Study of functional status 
Disability Rating Scale (DRS). It is an instrument that evaluates functional recovery 
in patients with moderate and severe traumatic brain injuries from coma to their 
return to society, taking into account cognitive function (Wright, 2008). 

[Escriba aquí] 
FFFF 
[Escriba aquí] 
 
2.Working plan 
Information will be obtained from each participant at three specific times: before the 
implementation of the intervention (screening and baseline: Phase 1), after the end of the 
intervention (Phase 2) and 6 months after the end of the intervention (Phase 3). Next, each of 
the stages and the tests that would be administered are detailed. 

Neuropsychological 
Screening 
Evaluation: 
- Cognitive 
- Attentional 
- Emotional 
- Functional 
-  Quality of life 
 
Evaluation: 
- Cognitive 
- Attentional 
- Emotional 
- Functional 
-  Quality of life 
 
 
 
 
Experimental   
(ABI) 
 
Aita Menni 
Acquired Brain 
Injury Unit 
 
 
                                                                                                              Control (ABI) 
 
 
 
                 
 Evaluation: 
- Cognitive 
- Attentional 
- Emotional 
- Functional 
-  Quality of life 
 
Evaluation: 
- Cognitive 
- Attentional 
- Emotional 
- Functional 
-  Quality of life 
 
Evaluation: 
- Cognitive 
- Attentional 
- Emotional 
- Functional 
-  Quality of life 
 Evaluation: 
- Cognitive 
- Attentional 
- Emotional 
- Functional 
-  Quality of life