Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury

Cognition Disorders Clinical Trial

— SOCCER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03479970
• Other study ID #: 2017257
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: January 2, 2022

Study information

• Verified date: February 2020
• Source: Institut Guttmann
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: January 2, 2022
• Est. primary completion date: January 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cognition Disorders

Intervention

Other:
• GNPT+ Social Cognition
Aplication of a computer based treatment focused on attention, memory, executive functions and social cognition.
• GNPT
It's a computeritzed program of cognitive telerehabilitation

Locations

Country	Name	City	State
Spain	Hospital de Neurorehabilitació Institut Guttmann	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Guttmann

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Affect Picture System (IAPS)	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.	1 day
Primary	Pictures of facial Affect (POFA)	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	1 day
Primary	The Moving Shapes Paradigm	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	1 day
Primary	Reading The Mind in the Eyes Test (RMET)	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.	1 day
Primary	Social Decision Making Task The Social Decision Making Task (SDMT)	Pseudo online test of catch and throw where the participant is required to use social feedback.	1 day
Secondary	Conners Continuous Performance Test (CPT-II)	To improve performance in sustained attention after receiving experimental intervention. Puntuation range from 0 to 100. The correct puntuation ranges from 40 to 60.	1 day
Secondary	Rey Auditory Verbal Learning Test (RAVLT)	To improve performance in short-term, long-term and recognition. This test has puntuation range from 0 to 75.	1 day
Secondary	Spanish phonemic fluency test- PMR	To 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.	1 day
Secondary	Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)	To 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.	1 day
Secondary	Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)	To 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.	1 day
Secondary	Letter-Number Sequencing Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)	To 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.	1 day
Secondary	Digit Symbol-Coding Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)	To 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.	1 day
Secondary	Block Design Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)	To 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.	1 day
Secondary	Stroop Color and Word test (Stroop Test)	To 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.	1 day
Secondary	Trail Making Test A (TMT-A)	To 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.	1 day
Secondary	Trail Making Test B (TMT-B)	To 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.	1 day
Secondary	Wisconsin Card Sorting Test (WCST)	To 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.	1 day