Clinical trial NCT03479970: Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury
Official title: Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury. Efficiency of a Computer Rehabilitation Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognition Disorders
Lead sponsor: Institut Guttmann
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: International Affect Picture System (IAPS)
timeFrame: 1 day
measure: Pictures of facial Affect (POFA)
timeFrame: 1 day
measure: The Moving Shapes Paradigm
timeFrame: 1 day
measure: Reading The Mind in the Eyes Test (RMET)
timeFrame: 1 day
measure: Social Decision Making Task The Social Decision Making Task (SDMT)
timeFrame: 1 day
Secondary outcomes:
measure: Conners Continuous Performance Test (CPT-II)
timeFrame: 1 day
measure: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: 1 day
measure: Spanish phonemic fluency test- PMR
timeFrame: 1 day
measure: Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
timeFrame: 1 day
measure: Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
timeFrame: 1 day
measure: Letter-Number Sequencing Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
timeFrame: 1 day
measure: Digit Symbol-Coding Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
timeFrame: 1 day
measure: Block Design Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
timeFrame: 1 day
measure: Stroop Color and Word test (Stroop Test)
timeFrame: 1 day
measure: Trail Making Test A (TMT-A)
timeFrame: 1 day
measure: Trail Making Test B (TMT-B)
timeFrame: 1 day
measure: Wisconsin Card Sorting Test (WCST)
timeFrame: 1 day
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital de Neurorehabilitació Institut Guttmann
state: Barcelona
Study officials:
affiliation: Institut Guttmann
name: Pablo Rodríguez
role: PRINCIPAL_INVESTIGATOR
References:
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. 2024 Jul-Aug;31(4):540-553. doi: 10.1080/23279095.2022.2042693. Epub 2022 Feb 23.