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Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury

Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury. Efficiency of a Computer Rehabilitation Treatment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03479970
Acronym
SOCCER
Enrollment
45
Registered
2018-03-27
Start date
2018-01-02
Completion date
2022-01-02
Last updated
2020-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition Disorders

Brief summary

In the present study the investigators aim to analyze the performance in a battery of social cognition tests of subjects with traumatic brain injury. On the other hand, the effectiveness of a computerized rehabilitation program designed to improve these deficits will be tested, as well as the relationship between social cognition and executive functioning.

Detailed description

The ability of the individual to know how to adopt the perspective of the other or be able to interpret and correctly identify their emotions, is essential for their proper development in society. The term Social Cognition would be the construct that would encompass these cognitive processes. People who have suffered a moderate or severe traumatic brain injury usually show, as reflected in the existing literature, an alteration in the functioning of Social Cognition, leading to problematic or inappropriate behaviors. These deficits have devastating consequences, at a personal, family and economic / labor level. There is an important debate regarding the independence of the Social Cognition construct from the rest of cognitive functions and in particular with respect to executive functions, probably due to the overlapping of the neuroanatomical structures related to each of these functions. In the present study a clinical trial will be conducted with a sample of 30 patients admitted to the Guttmann Institute Neurorehabilitation Hospital who have suffered a moderate or severe TBI. Patients will be divided into two groups depending on whether they receive cognitive rehabilitation treatment focused on attention, memory and executive functions (Control Group) or if, in addition to this treatment, the computerized treatment module for the rehabilitation of CS is also applied. (Experimental Group). Both types of treatment would be carried out using the cognitive telerehabilitation platform Guttmann, NeuroPersonalTrainer® (GNPT). The purpose of this study is to analyze the altered dimensions in the Social Cognition construct after having suffered a traumatic brain injury and to test the effectiveness of a computerized rehabilitation treatment designed for neuropsychologists with the aim of stimulating the relearning of these skills. In the same way it is tried to establish and to clarify the existing relation between the construct of the social cognition and other cognitive functions as they can be the executive functions

Interventions

OTHERGNPT+ Social Cognition

Aplication of a computer based treatment focused on attention, memory, executive functions and social cognition.

OTHERGNPT

It's a computeritzed program of cognitive telerehabilitation

Sponsors

Institut Guttmann
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age at the time of the TBI equal to or greater than 18 years. * Evolution time between the TBI and the beginning of the participation in the study less than 6 months. * Find out from the Post-Traumatic Amnesia Phase, evaluated through the Galveston Orientation and Amnesia Test (GOAT) scale: it is considered that the patient is out of PTA if he obtains scores greater than 75 in two consecutive administrations. * Cognitive impairment through the neuropsychological scan battery that is administered by clinical protocol.

Exclusion criteria

* Alteration of the language that compromises the complete application of the neuropsychological exploration battery. * Psychiatric history or neurological involvement prior to TBI.

Design outcomes

Primary

MeasureTime frameDescription
International Affect Picture System (IAPS)1 dayDesigned to provide a standardized set of pictures for studying emotion and attention. This subtest has a puntuation range from 0 to 25, where higher values are considered to be a better outcome.
Pictures of facial Affect (POFA)1 dayIt is an assessment test of the ability to identify basic emotions in facial. This subtest has a puntuation range from 0 to 65, where higher values are considered to be a better outcome. expressions
The Moving Shapes Paradigm1 dayEvaluation of the interaction between two triangles based on low level. This subtest has a puntuation range from 0 to 12, where higher values are considered to be a better outcome. inferences
Reading The Mind in the Eyes Test (RMET)1 dayAdvanced test of theory of mind. The subject must identify emotions in the eyes of photographed people. This subtest has a puntuation range from 0 to 36, where higher values are considered to be a better outcome.
Social Decision Making Task The Social Decision Making Task (SDMT)1 dayPseudo online test of catch and throw where the participant is required to use social feedback.

Secondary

MeasureTime frameDescription
Letter-Number Sequencing Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)1 dayTo improve performance in working memory after receiving experimental intervention. This subtest has a puntation range from 1 to 21, where higher values are considered to be a better outcome.
Digit Symbol-Coding Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)1 dayTo improve performance in speed of processing. This subtest has a puntuation range from 1 to 133, where higher values are considered to be a better outcome.
Block Design Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)1 dayTo improve performance in visuoconstruction and planning. This subtest has a puntuation range from 1 to 68, where higher values are considered to be a better outcome.
Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)1 dayTo improve performance in span of immediate verbal recall after receiving experimental intervention. This subtest has a puntuation range from 2 to 9, where higher values are considered to be a better outcome.
Trail Making Test A (TMT-A)1 dayTo improve performance in visual attention. This subtest has a puntuation range from 1 to 999 seconds, where higher values are considered to be a worst outcome.
Trail Making Test B (TMT-B)1 dayTo improve performance in task-switching. This subtest has a puntuation range from 1 to 999 seconds, where higher values are considered to be a worst outcome.
Wisconsin Card Sorting Test (WCST)1 dayTo improve performance in cognitive flexibility. This subtest has a puntuation range from 1 to 6 categories, where higher values are considered to be a better outcome.
Stroop Color and Word test (Stroop Test)1 dayTo improve performance in inhibitory control. This subtest has a puntuation range from 1 to 100, where higher values are considered to be a better outcome.
Conners Continuous Performance Test (CPT-II)1 dayTo improve performance in sustained attention after receiving experimental intervention. Puntuation range from 0 to 100. The correct puntuation ranges from 40 to 60.
Rey Auditory Verbal Learning Test (RAVLT)1 dayTo improve performance in short-term, long-term and recognition. This test has puntuation range from 0 to 75.
Spanish phonemic fluency test- PMR1 dayTo improve performance in phonemic fluency after receiving experimental intervention. This subtest has a puntuation range from 0 to 100, where higher values are considered to be a better outcome.
Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)1 dayTo improve performance in working memory after receiving experimental intervention. This subtest has a puntuation range from 2 to 8, where higher values are considered to be a better outcome.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026