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

Primary Purpose

Cognition Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
GNPT+ Social Cognition
GNPT
Sponsored by
Institut Guttmann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognition Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Neurorehabilitació Institut Guttmann

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GNPT + Social Cognition

GNPT (only N-SC measures)

Arm Description

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

Control Group: will only conduct a cognitive rehabilitation treatment through the cognitive telerehabilitation platform Guttmann, NeuroPersonalTrainer® (GNPT) focused on attention, memory and executive functions.

Outcomes

Primary Outcome Measures

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.
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
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
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 20, 2018
Last Updated
February 11, 2020
Sponsor
Institut Guttmann
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1. Study Identification

Unique Protocol Identification Number
NCT03479970
Brief Title
Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury
Acronym
SOCCER
Official Title
Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury. Efficiency of a Computer Rehabilitation Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
January 2, 2021 (Anticipated)
Study Completion Date
January 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut Guttmann

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GNPT + Social Cognition
Arm Type
Experimental
Arm Description
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
Arm Title
GNPT (only N-SC measures)
Arm Type
Active Comparator
Arm Description
Control Group: will only conduct a cognitive rehabilitation treatment through the cognitive telerehabilitation platform Guttmann, NeuroPersonalTrainer® (GNPT) focused on attention, memory and executive functions.
Intervention Type
Other
Intervention Name(s)
GNPT+ Social Cognition
Intervention Description
Aplication of a computer based treatment focused on attention, memory, executive functions and social cognition.
Intervention Type
Other
Intervention Name(s)
GNPT
Intervention Description
It's a computeritzed program of cognitive telerehabilitation
Primary Outcome Measure Information:
Title
International Affect Picture System (IAPS)
Description
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.
Time Frame
1 day
Title
Pictures of facial Affect (POFA)
Description
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
Time Frame
1 day
Title
The Moving Shapes Paradigm
Description
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
Time Frame
1 day
Title
Reading The Mind in the Eyes Test (RMET)
Description
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.
Time Frame
1 day
Title
Social Decision Making Task The Social Decision Making Task (SDMT)
Description
Pseudo online test of catch and throw where the participant is required to use social feedback.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Conners Continuous Performance Test (CPT-II)
Description
To improve performance in sustained attention after receiving experimental intervention. Puntuation range from 0 to 100. The correct puntuation ranges from 40 to 60.
Time Frame
1 day
Title
Rey Auditory Verbal Learning Test (RAVLT)
Description
To improve performance in short-term, long-term and recognition. This test has puntuation range from 0 to 75.
Time Frame
1 day
Title
Spanish phonemic fluency test- PMR
Description
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.
Time Frame
1 day
Title
Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Description
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.
Time Frame
1 day
Title
Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Description
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.
Time Frame
1 day
Title
Letter-Number Sequencing Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Description
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.
Time Frame
1 day
Title
Digit Symbol-Coding Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Description
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.
Time Frame
1 day
Title
Block Design Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Description
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.
Time Frame
1 day
Title
Stroop Color and Word test (Stroop Test)
Description
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.
Time Frame
1 day
Title
Trail Making Test A (TMT-A)
Description
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.
Time Frame
1 day
Title
Trail Making Test B (TMT-B)
Description
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.
Time Frame
1 day
Title
Wisconsin Card Sorting Test (WCST)
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Rodríguez
Organizational Affiliation
Institut Guttmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Neurorehabilitació Institut Guttmann
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35196474
Citation
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.
Results Reference
derived

Learn more about this trial

Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury

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