Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury (SOCCER)

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

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.

Study Overview

• Status: Unknown
• Conditions: Cognition Disorders
• Intervention / Treatment: Other: GNPT+ Social Cognition; Other: GNPT

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

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital de Neurorehabilitació Institut Guttmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GNPT + Social Cognition; Experimental Group: will undertake a rehabilitation treatment integrated by a set of tasks aimed at working attention, memory and executive functions together with a computerized treatment for the rehabilitation of the Social Cognition. The treatment will be carried out through the cognitive telerehabilitation platform Guttmann, NeuroPersonalTrainer® (GNPT). The treatment will consist of the carrying out of 24 treatment sessions	Other: GNPT+ Social Cognition; Aplication of a computer based treatment focused on attention, memory, executive functions and social cognition.
Active Comparator: GNPT (only N-SC measures); Control Group: will only conduct a cognitive rehabilitation treatment through the cognitive telerehabilitation platform Guttmann, NeuroPersonalTrainer® (GNPT) focused on attention, memory and executive functions.	Other: GNPT; It's a computeritzed program of cognitive telerehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Institut Guttmann
• Investigators: Principal Investigator: Pablo Rodríguez, Institut Guttmann

Publications and helpful links

General Publications

• Rodriguez-Rajo P, Garcia-Rudolph A, Sanchez-Carrion R, Aparicio-Lopez C, Ensenat-Cantallops A, Garcia-Molina A. Computerized social cognitive training in the subacute phase after traumatic brain injury: A quasi-randomized controlled trial. Appl Neuropsychol Adult. 2022 Feb 23:1-14. doi: 10.1080/23279095.2022.2042693. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Anticipated): January 2, 2021
• Study Completion (Anticipated): January 2, 2022

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Cognition Disorders
• Other Study ID Numbers: 2017257

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No