ClinicalTrials.gg
Status unknownNCT03479970SOCCERUpdated Feb 13, 2020

Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury

An interventional study of GNPT+ Social Cognition and GNPT in Cognition Disorders, sponsored by Institut Guttmann. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-13.

Sponsored by Institut Guttmann · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Cognition Disorders

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03

In context

Cognition Disorders

419 studies on the registry are indexed under Cognition Disorders; 89 are open to participants now.

This study's enrollment of 45 is below the median of 60 across 294 interventional studies indexed under Cognition Disorders.

Browse Cognition Disorders studies →

Lead sponsor

Institut Guttmann is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Alteration of the language that compromises the complete application of the neuropsychological exploration battery.
  • Psychiatric history or neurological involvement prior to TBI.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
45 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherGNPT+ Social Cognition

    Aplication of a computer based treatment focused on attention, memory, executive functions and social cognition.

  • OtherGNPT

    It's a computeritzed program of cognitive telerehabilitation

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. 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

    Time frame: 1 day

  3. 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

    Time frame: 1 day

  4. 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.

    Time frame: 1 day

  5. 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.

    Time frame: 1 day

Secondary outcomes

  1. 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.

    Time frame: 1 day

  2. 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.

    Time frame: 1 day

  3. 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.

    Time frame: 1 day

  4. 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.

    Time frame: 1 day

  5. 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.

    Time frame: 1 day

  6. 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.

    Time frame: 1 day

  7. 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.

    Time frame: 1 day

  8. 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.

    Time frame: 1 day

  9. 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.

    Time frame: 1 day

  10. 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.

    Time frame: 1 day

  11. 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.

    Time frame: 1 day

  12. 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.

    Time frame: 1 day

07

Study locations

1 site
  • Hospital de Neurorehabilitació Institut Guttmann
    Badalona, Barcelona 08916, Spain
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References and documents

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. 2024 Jul-Aug;31(4):540-553. doi: 10.1080/23279095.2022.2042693. Epub 2022 Feb 23. PubMed 35196474 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03479970
Lead sponsor
Institut Guttmann
Responsible party
Pablo Rodriguez (Principal Investigator, Institut Guttmann) — Principal investigator
First posted
Mar 27, 2018
Start date
Jan 2, 2018
Primary completion
Jan 2, 2021 (estimated)
Completion
Jan 2, 2022 (estimated)
Last update
Feb 13, 2020

Study contacts

Pablo Rodríguez
principal investigator · Institut Guttmann

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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