Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury
SOCCER
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2018
CompletedFirst Submitted
Initial submission to the registry
March 20, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2022
CompletedFebruary 13, 2020
February 1, 2020
3 years
March 20, 2018
February 11, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
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.
1 day
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
1 day
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
1 day
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.
1 day
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.
1 day
Secondary Outcomes (12)
Conners Continuous Performance Test (CPT-II)
1 day
Rey Auditory Verbal Learning Test (RAVLT)
1 day
Spanish phonemic fluency test- PMR
1 day
Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
1 day
Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
1 day
- +7 more secondary outcomes
Study Arms (2)
GNPT + Social Cognition
EXPERIMENTALExperimental 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
GNPT (only N-SC measures)
ACTIVE COMPARATORControl Group: will only conduct a cognitive rehabilitation treatment through the cognitive telerehabilitation platform Guttmann, NeuroPersonalTrainer® (GNPT) focused on attention, memory and executive functions.
Interventions
Aplication of a computer based treatment focused on attention, memory, executive functions and social cognition.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Alteration of the language that compromises the complete application of the neuropsychological exploration battery.
- Psychiatric history or neurological involvement prior to TBI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Neurorehabilitació Institut Guttmann
Badalona, Barcelona, 08916, Spain
Related Publications (1)
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.
PMID: 35196474DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pablo Rodríguez
Institut Guttmann
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 20, 2018
First Posted
March 27, 2018
Study Start
January 2, 2018
Primary Completion
January 2, 2021
Study Completion
January 2, 2022
Last Updated
February 13, 2020
Record last verified: 2020-02