Efficacy of a Computerized Program of Cognitive Rehabilitation of Attention in People With Acquired Brain Injury (ABI)
NCT04214314, Unknown, Ikerbasque - Basque Foundation for Science
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Efficacy of a Computerized Program of Cognitive Rehabilitation of Attention in People With Acquired Brain Injury (ABI) | ClinicalTrials.gov |
| NCT number | NCT04214314 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Enrollment | 46 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Ikerbasque - Basque Foundation for Science | ClinicalTrials.gov |
| Conditions | Brain Injuries | ClinicalTrials.gov |
| Interventions | NeuronUp APT attentional program | ClinicalTrials.gov |
| First posted | 2020-01-02 | ClinicalTrials.gov |
| Last updated | 2021-02-17 | ClinicalTrials.gov |
Registered outcomes 21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Short attention test (BTA): changes in the measure before the intervention (pre-intervention), after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | 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. | ClinicalTrials.gov |
| Primary | Trail Making Test (TMT A-B): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | The test is used to evaluate attention, psychomotor speed, cognitive flexibility, visual search and executive functions. | ClinicalTrials.gov |
| Primary | Test of Colors and Words (Stroop Test): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | It provides information on the inhibitory capacity of the subject and its resistance to stimulus interference. | ClinicalTrials.gov |
| Primary | Symbol and digit test (SDMT): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | 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. | ClinicalTrials.gov |
| Primary | PASAT test: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | This 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. | ClinicalTrials.gov |
| Primary | Bells Test: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | The Bells Test 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 | ClinicalTrials.gov |
| Primary | Attention Test D2: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | This test 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 attention. | ClinicalTrials.gov |
| Primary | Minimental State Examination (MMSE): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | 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.The scores of MMSE are 0 to 30. In this study the participants need to have a score major 23 for participate. Because, if the score is less or equal 23 in this test, the participant can have an important cognitive deficits. | ClinicalTrials.gov |
| Secondary | Hopkins Verbal Learning Test - Revised (HVLT-R): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | 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. | ClinicalTrials.gov |
| Secondary | Test of the complex figure of Rey: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | 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. | ClinicalTrials.gov |
| Secondary | Modified test of classification of Wisconsin cards (M-WCST): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | 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 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. | ClinicalTrials.gov |
| Secondary | Boston Denomination Test (BNT): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | The test consists of naming 60 sheets presented in order of difficulty. Its test-retest reliability coefficients are above 0.77 and has demonstrated good internal consistency with indexes greater than 0, 78. | ClinicalTrials.gov |
| Secondary | Phonological and Semantic Verbal Fluency Test: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | 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.).These tests require the person to be flexible, organize the information and exercise inhibition when necessary. | ClinicalTrials.gov |
| Secondary | European Brain Injury Questionnaire (EBIQ): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | 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. | ClinicalTrials.gov |
| Secondary | Questionnaire of attention problems: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | 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. | ClinicalTrials.gov |
| Secondary | Moss Attention Rating Scale (MARS): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | 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). | ClinicalTrials.gov |
| Secondary | Patient Health Questionnaire (PHQ-9): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | 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. | ClinicalTrials.gov |
| Secondary | Generalized Anxiety Disorders Scale (GAD-7): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | 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. | ClinicalTrials.gov |
| Secondary | Quality of life scale (SF-36): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | 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. | ClinicalTrials.gov |
| Secondary | Life Satisfaction Scale (SWLS): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 22
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 1955532 | BACKGROUND | PubMed |
| 3558744 | BACKGROUND | PubMed |
| 7645662 | BACKGROUND | PubMed |
| 7874099 | BACKGROUND | PubMed |
| 9111453 | BACKGROUND | PubMed |
| 10785624 | BACKGROUND | PubMed |
| 10887887 | BACKGROUND | PubMed |
| 11094401 | BACKGROUND | PubMed |
| 11778779 | BACKGROUND | PubMed |
| 11874612 | BACKGROUND | PubMed |
| 12633489 | BACKGROUND | PubMed |
| 15204316 | BACKGROUND | PubMed |
| 15908840 | BACKGROUND | PubMed |
| 17342680 | BACKGROUND | PubMed |
| 18039889 | BACKGROUND | PubMed |
| 18452747 | BACKGROUND | PubMed |
| 19210031 | BACKGROUND | PubMed |
| 21108231 | BACKGROUND | PubMed |
| 22897509 | BACKGROUND | PubMed |
| 26889800 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Cancellation Test | Primary outcome | ConductCognition |
| Paced Visual Serial Addition Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)