Cognition DisordersSOCCERNCT03479970
Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury
A study testing GNPT+ Social Cognition and GNPT in people with Cognition Disorders, run by Institut Guttmann at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognition Disorders
- What is being tested?
- GNPT+ Social Cognition and GNPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jan 2018to 2 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Alteration of the language that compromises the complete application of the neuropsychological exploration battery.
- Psychiatric history or neurological involvement prior to TBI.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital de Neurorehabilitació Institut Guttmann
Badalona, Barcelona, 08916
About this study
Official title: Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury. Efficiency of a Computer Rehabilitation Treatment
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
- Conditions
- Cognition Disorders
- Being tested
- GNPT+ Social Cognition, GNPT
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNPT+ Social CognitionOther
Aplication of a computer based treatment focused on attention, memory, executive functions and social cognition.
GNPTOther
It's a computeritzed program of cognitive telerehabilitation
| Study group | Role | What they receive |
|---|---|---|
| GNPT + Social Cognition | Experimental | 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 Receives: Other: GNPT+ Social Cognition |
| GNPT (only N-SC measures) | Active comparator | Control Group: will only conduct a cognitive rehabilitation treatment through the cognitive telerehabilitation platform Guttmann, NeuroPersonalTrainer® (GNPT) focused on attention, memory and executive functions. Receives: Other: GNPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 1 day
Secondary outcomes (12)
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start2 Jan 2018
- Primary completion2 Jan 2021 (estimated)
- Study completion2 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Guttmann
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Rodriguez, Institut Guttmann
- Investigators
- Pablo Rodríguez, Principal investigator, Institut Guttmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479970
- Sponsor's protocol ID
- 2017257
- Acronym
- SOCCER
- Status last verified
- Feb 2020
- First submitted
- 20 Mar 2018
- Last updated
- 13 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury. Efficiency of a Computer Rehabilitation Treatment
- ClinicalTrials.gov ID
- NCT03479970
- Acronym / sponsor ID
- SOCCER / 2017257
- Conditions
- Cognition Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Institut GuttmannUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 2 Jan 2021 (estimated)
- Study completion
- 2 Jan 2022 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GNPT + Social Cognition | Experimental | Other: GNPT+ Social CognitionExperimental 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 comparator | Other: GNPTControl Group: will only conduct a cognitive rehabilitation treatment through the cognitive telerehabilitation platform Guttmann, NeuroPersonalTrainer® (GNPT) focused on attention, memory and executive functions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Alteration of the language that compromises the complete application of the neuropsychological exploration battery.
- Psychiatric history or neurological involvement prior to TBI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GNPT+ Social CognitionAplication of a computer based treatment focused on attention, memory, executive functions and social cognition. | Other | GNPT + Social Cognition |
| GNPTIt's a computeritzed program of cognitive telerehabilitation | Other | GNPT (only N-SC measures) |
Primary outcome
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.
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
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
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.
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.
12 secondary outcomes
Conners Continuous Performance Test (CPT-II)
Time frame: 1 day
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: 1 day
Spanish phonemic fluency test- PMR
Time frame: 1 day
Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Time frame: 1 day
Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Time frame: 1 day
Letter-Number Sequencing Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Time frame: 1 day
Digit Symbol-Coding Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Time frame: 1 day
Block Design Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Time frame: 1 day
Stroop Color and Word test (Stroop Test)
Time frame: 1 day
Trail Making Test A (TMT-A)
Time frame: 1 day
Trail Making Test B (TMT-B)
Time frame: 1 day
Wisconsin Card Sorting Test (WCST)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Derived from this study: PubMed 35196474Rodriguez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Rodríguez principal investigator
Institut Guttmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GNPT+ Social Cognition and GNPT in people with Cognition Disorders, run by Institut Guttmann at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Affect Picture System (IAPS) (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03479970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.