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

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ClinicalTrials.gov Identifier: NCT03479970
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Guttmann

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.


Condition or disease Intervention/treatment Phase
Cognition Disorders Other: GNPT+ Social Cognition Other: GNPT Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury. Efficiency of a Computer Rehabilitation Treatment
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : January 2, 2021
Estimated Study Completion Date : January 2, 2022

Resource links provided by the National Library of Medicine


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
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




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. Conners Continuous Performance Test (CPT-II) [ Time Frame: 1 day ]
    To improve performance in sustained attention after receiving experimental intervention. Puntuation range from 0 to 100. The correct puntuation ranges from 40 to 60.

  2. Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: 1 day ]
    To improve performance in short-term, long-term and recognition. This test has puntuation range from 0 to 75.

  3. Spanish phonemic fluency test- PMR [ Time Frame: 1 day ]
    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.

  4. Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) [ Time Frame: 1 day ]
    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.

  5. Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) [ Time Frame: 1 day ]
    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.

  6. Letter-Number Sequencing Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) [ Time Frame: 1 day ]
    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.

  7. Digit Symbol-Coding Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) [ Time Frame: 1 day ]
    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.

  8. Block Design Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) [ Time Frame: 1 day ]
    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.

  9. Stroop Color and Word test (Stroop Test) [ Time Frame: 1 day ]
    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.

  10. Trail Making Test A (TMT-A) [ Time Frame: 1 day ]
    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.

  11. Trail Making Test B (TMT-B) [ Time Frame: 1 day ]
    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.

  12. Wisconsin Card Sorting Test (WCST) [ Time Frame: 1 day ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479970


Contacts
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Contact: Pablo Rodríguez +34 93 497 77 00 ext 2297 prodriguez@guttmann.com

Locations
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Spain
Hospital de Neurorehabilitació Institut Guttmann Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Jose Maria Tormos, Dr.    +34 93 497 77 00 ext 2155    jmtormos@guttmann.com   
Sponsors and Collaborators
Institut Guttmann

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Responsible Party: Institut Guttmann
ClinicalTrials.gov Identifier: NCT03479970     History of Changes
Other Study ID Numbers: 2017257
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

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

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Neurocognitive Disorders
Mental Disorders