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Clinical Trials/NCT03479970
NCT03479970
Unknown
N/A

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

Institut Guttmann1 site in 1 country45 target enrollmentJanuary 2, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cognition Disorders
Sponsor
Institut Guttmann
Enrollment
45
Locations
1
Primary Endpoint
Pictures of facial Affect (POFA)
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 2, 2018
End Date
January 2, 2022
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Institut Guttmann
Responsible Party
Principal Investigator
Principal Investigator

Pablo Rodriguez

Principal Investigator

Institut Guttmann

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Pictures of facial Affect (POFA)

Time Frame: 1 day

It 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

Social Decision Making Task The Social Decision Making Task (SDMT)

Time Frame: 1 day

Pseudo online test of catch and throw where the participant is required to use social feedback.

International Affect Picture System (IAPS)

Time Frame: 1 day

Designed 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.

The Moving Shapes Paradigm

Time Frame: 1 day

Evaluation 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)

Time Frame: 1 day

Advanced 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.

Secondary Outcomes

  • Rey Auditory Verbal Learning Test (RAVLT)(1 day)
  • Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)(1 day)
  • Conners Continuous Performance Test (CPT-II)(1 day)
  • Spanish phonemic fluency test- PMR(1 day)
  • Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)(1 day)
  • Letter-Number Sequencing Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)(1 day)
  • Digit Symbol-Coding Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)(1 day)
  • Block Design Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)(1 day)
  • Stroop Color and Word test (Stroop Test)(1 day)
  • Trail Making Test A (TMT-A)(1 day)
  • Trail Making Test B (TMT-B)(1 day)
  • Wisconsin Card Sorting Test (WCST)(1 day)

Study Sites (1)

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