Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury

NCT ID: NCT03479970

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2022-01-02

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

Conditions

Cognition Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

GNPT+ Social Cognition

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

GNPT

Intervention Type: OTHER

It's a computeritzed program of cognitive telerehabilitation

Interventions

GNPT+ Social Cognition

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

Intervention Type: OTHER

GNPT

It's a computeritzed program of cognitive telerehabilitation

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Guttmann

OTHER

Sponsor Role: lead

Responsible Party

Pablo Rodriguez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pablo Rodríguez

Role: PRINCIPAL_INVESTIGATOR

Institut Guttmann

Locations

Hospital de Neurorehabilitació Institut Guttmann

Badalona, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 35196474 (View on PubMed)

Other Identifiers

2017257

Identifier Type: -

Identifier Source: org_study_id