Traumatic Brain InjuryNCT03382626
Transcranial Direct Current Stimulation and Computer-based Training for the Traumatic Brain Injury Rehabilitation
A study testing anodal tDCS and Computer-assisted training in people with Traumatic Brain Injury, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Traumatic Brain Injury (TBI) is a serious public health problem due to its high mortality and morbidity rates, mainly affecting young adult males. Aggression to the prefrontal cortex, caused by an external physical force, responsible for anatomical injury and/or functional impairment, causes cognitive deficits with… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- anodal tDCS and Computer-assisted training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Feb 2018to Oct 2019
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic TBI (≥ 12 months)
- Severe TBI (Glasgow ≤ 8, loss of consciousness > 24 hours, post-traumatic amnesia > 1 week)
- Working memory, attention or executive deficit
- Score in Mini Mental State Examination according the cut-off point (i.e, 13 to illiterates individuals, 18 to low and medium schooling and 26 to high schooling).
Who cannot join
- Individuals unable to perform the activities proposed in the study protocol (e.g. physical deficits, lack of collaboration, aphasia, accuses, amaurosis)
- Mid or extensive cranial defects
- Titanium cranial prosthesis
- Extensive cranial prosthesis located on the dorsal prefrontal cortex
- Metallic devices implanted in the brain
- Psychotic disorders
- Recent history of alcoholism or use of drugs
- Neurological diseases (e.g Parkinson, Stroke, Alzheimer).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Ambulatório de Reabilitação Cognitiva do Hospital das Clínicas da Universidade de São Paulo
São Paulo
Amanda Vitória Lacerda de Araújo, Master, 11971212653, amandavitooria@gmail.com
About this study
Official title: Transcranial Direct Current Stimulation and Computer-based Training for the Rehabilitation of Cognitive Function in Traumatic Brain Injury: a Randomized Controlled Trial
Traumatic Brain Injury (TBI) is a serious public health problem due to its high mortality and morbidity rates, mainly affecting young adult males. Aggression to the prefrontal cortex, caused by an external physical force, responsible for anatomical injury and/or functional impairment, causes cognitive deficits with important consequences for the individual affected by the trauma and their caregivers. Therefore, rehabilitation is of utmost importance. The increase in pre-frontal cortical activation through training, activity-dependent stimulation and neuroplasticity, especially in the dorsolateral prefrontal cortex (DLPFC) is related to better performance in functional memory. In this context, Transcranial Direct Current Stimulation (tDCS), intended to drive neuroplastic changes in the brain, has been widely used to bring benefits to the cognitive function of individuals affected by various neurological conditions, including TBI by promoting neuroplasticity for critically involved cortical areas in the performance of tasks, culminating in cognitive benefits. In addition, studies have shown greater benefits when the technique is combined with cognitive training. Therefore, the objective of this parallel, randomized, double-blind, placebo-controlled clinical trial is to investigate the effect of tDCS applied on the dorsolateral prefrontal cortex and virtual reality cognitive training alone or in association with tDCS on cognitive function of individuals with severe chronic TBI.
- Conditions
- Traumatic Brain Injury
- Being tested
- anodal tDCS, Computer-assisted training, sham tDCS
- Keywords
- Traumatic Brain Injury, Transcranial Direct Current Stimulation, Computer-assisted training, Cognitive training, Cognitive function, Executive function, Working memory, Attention
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anodal tDCSDevice
Anodal tDCS will be applied on the left prefrontal cortex dorsolateral (F3 area using International 10-20 system for EEG electrode placement) with the following parameters: electrode size of 25-35 cm², 2mA, 0.057 mA/cm² and duration of 20 minutes. The cathode will be placed over the supra-orbital region.
Computer-assisted trainingDevice
The computer-assisted cognitive training will consist of games with visual and auditory stimuli to improve working memory, attention, and executive function. The games will be Genius and Labyrinth games, reaction time and timing-coincident.
sham tDCSDevice
Sham tDCS will be applied with the same parameters and electrode placement of active anodal tDCS. However, the current flow will be interrupted by the device after few seconds.
| Study group | Role | What they receive |
|---|---|---|
| tDCS plus Computer-assisted training | Active comparator | Patients will receive 10 sessions of active anodal tDCS on the left prefrontal cortex dorsolateral (F3 area using International 10-20 system for electroencephalogram (EEG) electrode placement) plus Computer-assisted cognitive training (games to improve working memory, attention, and executive function). Receives: Device: anodal tDCS; Device: Computer-assisted training |
| tDCS sham plus Computer-assisted training | Sham comparator | Patients will receive 10 sessions of sham anodal tDCS on the left prefrontal cortex dorsolateral plus Computer-assisted cognitive training (games to improve working memory, attention and executive function). Receives: Device: Computer-assisted training; Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline working memory at 10 days of intervention (scale assessment)
Will be performed throughWechsler Adult Intelligence Scale IV (Digit span, Letter-Number Sequencing and Arithmetic subtests). These subtests evaluates the working memory and attention. The Digit span involves a forward and a backward recitation condition. The maximum score is 30 points, where higher score indicates better the performance. Letter-Number sequencing involves a combination of numbers and letters that must be recited.The maximum scores is 21 points, where higher scores shows better performance. The Arithmetic subtest is formed by some calculations must be solved without the aid of paper and pen. The maximum score is 22 points in which higher scores indicates better performance. The score of each subtest will be considered separately for characterization of the working memory. In addition, The sum of the weighted individual scores in each subtest will be calculated for the Working Memory Index.
Measured: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, i.e 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
Change from baseline working memory at 10 days of intervention (computer-based assessment)
This assessment will occur through the Genius game, which will evaluate the performance in the unit of measure of execution time (i.e. seconds) of the task.
Measured: We will apply these instruments at T0 (baseline time), T1 (one day after the first session), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
Change from baseline executive function at 10 days of intervention (scale assessment)
This assessment will occur through the Trail Making Test A and B, which provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. It requires the subject to connect encircled numbers randomly arranged on a page (Part A) and encircled numbers and letters in alternating order (Part B). Scoring is expressed in time in seconds required for completion of each of the two parts of the test. Scoring is expressed in terms of the time in seconds required for completion of each of the two parts of the test, on which the shorter the time to complete the task the better the performance (i.e part A < 180 s and part B < 300 s).
Measured: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
Change from baseline attention and executive function at 10 days of intervention (scale assessment)
This assessment will occur through the Stroop Color and Word Test, which assesses the ease with which a person can maintain a goal in mind and suppress the habitual response in favor of a less familiar one (i.e selective attention and cognitive flexibility). Both the time to complete and the number of errors. In addition, the interference effect is determined by calculating the extra time required to name colors in the interference task in comparison to the time required to name colors in the control task.
Measured: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
Change from baseline processing speed at 10 days of intervention (scale assessment)
This assessment will occur through the Code Search subtest (WAIS), which as evaluates the processing speed to complete a card with number and symbols that must be related to a correct execution of the test. The score is formulated based on correct answers. The maximum score is 133 points. The higher scores are related to better performance.
Measured: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
Secondary outcomes (4)
Change from baseline processing speed at 10 days of intervention (computer-based assessment)
This assessment will occur through the following instruments: Reaction time game and Timing Coincident game. These computer games measure the score in the unit of measure of time, where the lower the execution time the better the performance (i.e processing speed).
Measured: We will apply these instruments at T0 (baseline time), T1 (one day after the first session), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
Change from baseline reasoning and planning at 10 days of intervention (computer-based assessment)
This evaluation will be performed through the maze game, in which performance is measured by the task execution time. Thus, the shorter the execution time, the better the cognitive performance.
Measured: We will apply these instruments at T0 (baseline time), T1 (one day after the first session), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
Change from baseline quality of life at 10 days of intervention
This assessment will occur through Quality of Life After Brain Injury (QOLIBRI) scale, which is a comprehensive questionnaire with 37 items covering six dimensions (cognition, self, daily life and autonomy, social relationships, emotion and physical problems). The scale means are converted to the 0-100 scale by subtracting 1 from the mean and then multiplying by 25. This produces scale scores which have a lowest possible value of 0 (worst possible quality of life) and a maximum value of 100 (best possible quality of life).
Measured: We will apply the QOLIBRI at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
Change from baseline depression at 10 days of intervention
This assessment will occur through Beck Depression Inventory (BDI), which is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Measured: We will apply the BDI at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and and T3 (i.e after 1 month of follow-up time).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start19 Feb 2018
- Primary completion30 Nov 2018 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, double-blind, randomized, parallel, controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Anghinah, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382626
- Sponsor's protocol ID
- 71391917000000068
- Status last verified
- Nov 2018
- First submitted
- 4 Dec 2017
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation and Computer-based Training for the Rehabilitation of Cognitive Function in Traumatic Brain Injury: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03382626
- Acronym / sponsor ID
- 71391917000000068
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Transcranial Direct Current Stimulation, Computer-assisted training, Cognitive training, Cognitive function, Executive function, Working memory, Attention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 26 Dec 2017 (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.
Traumatic Brain Injury (TBI) is a serious public health problem due to its high mortality and morbidity rates, mainly affecting young adult males. Aggression to the prefrontal cortex, caused by an external physical force, responsible for anatomical injury and/or functional impairment, causes cognitive deficits with important consequences for the individual affected by the trauma and their caregivers. Therefore, rehabilitation is of utmost importance. The increase in pre-frontal cortical activation through training, activity-dependent stimulation and neuroplasticity, especially in the dorsolateral prefrontal cortex (DLPFC) is related to better performance in functional memory. In this context, Transcranial Direct Current Stimulation (tDCS), intended to drive neuroplastic changes in the brain, has been widely used to bring benefits to the cognitive function of individuals affected by various neurological conditions, including TBI by promoting neuroplasticity for critically involved cortical areas in the performance of tasks, culminating in cognitive benefits. In addition, studies have shown greater benefits when the technique is combined with cognitive training. Therefore, the objective of this parallel, randomized, double-blind, placebo-controlled clinical trial is to investigate the effect of tDCS applied on the dorsolateral prefrontal cortex and virtual reality cognitive training alone or in association with tDCS on cognitive function of individuals with severe chronic TBI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, double-blind, randomized, parallel, controlled study
| Arm | Type | Receives |
|---|---|---|
| tDCS plus Computer-assisted training | Active comparator | Device: anodal tDCS, Device: Computer-assisted trainingPatients will receive 10 sessions of active anodal tDCS on the left prefrontal cortex dorsolateral (F3 area using International 10-20 system for electroencephalogram (EEG) electrode placement) plus Computer-assisted cognitive training (games to improve working memory, attention, and executive function). |
| tDCS sham plus Computer-assisted training | Sham comparator | Device: Computer-assisted training, Device: sham tDCSPatients will receive 10 sessions of sham anodal tDCS on the left prefrontal cortex dorsolateral plus Computer-assisted cognitive training (games to improve working memory, attention and executive function). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chronic TBI (≥ 12 months)
- Severe TBI (Glasgow ≤ 8, loss of consciousness > 24 hours, post-traumatic amnesia > 1 week)
- Working memory, attention or executive deficit
- Score in Mini Mental State Examination according the cut-off point (i.e, 13 to illiterates individuals, 18 to low and medium schooling and 26 to high schooling).
Key exclusion criteria (8 listed)
- Individuals unable to perform the activities proposed in the study protocol (e.g. physical deficits, lack of collaboration, aphasia, accuses, amaurosis)
- Mid or extensive cranial defects
- Titanium cranial prosthesis
- Extensive cranial prosthesis located on the dorsal prefrontal cortex
- Metallic devices implanted in the brain
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 |
|---|---|---|
| anodal tDCSAnodal tDCS will be applied on the left prefrontal cortex dorsolateral (F3 area using International 10-20 system for EEG electrode placement) with the following parameters: electrode size of 25-35 cm², 2mA, 0.057 mA/cm² and duration of 20 minutes. The cathode will be placed over the supra-orbital region. | Device | tDCS plus Computer-assisted training |
| Computer-assisted trainingThe computer-assisted cognitive training will consist of games with visual and auditory stimuli to improve working memory, attention, and executive function. The games will be Genius and Labyrinth games, reaction time and timing-coincident. | Device | tDCS plus Computer-assisted training, tDCS sham plus Computer-assisted training |
| sham tDCSSham tDCS will be applied with the same parameters and electrode placement of active anodal tDCS. However, the current flow will be interrupted by the device after few seconds. | Device | tDCS sham plus Computer-assisted training |
Primary outcome
Change from baseline working memory at 10 days of intervention (scale assessment)
Time frame: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, i.e 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
Will be performed throughWechsler Adult Intelligence Scale IV (Digit span, Letter-Number Sequencing and Arithmetic subtests). These subtests evaluates the working memory and attention. The Digit span involves a forward and a backward recitation condition. The maximum score is 30 points, where higher score indicates better the performance. Letter-Number sequencing involves a combination of numbers and letters that must be recited.The maximum scores is 21 points, where higher scores shows better performance. The Arithmetic subtest is formed by some calculations must be solved without the aid of paper and pen. The maximum score is 22 points in which higher scores indicates better performance. The score of each subtest will be considered separately for characterization of the working memory. In addition, The sum of the weighted individual scores in each subtest will be calculated for the Working Memory Index.
Change from baseline working memory at 10 days of intervention (computer-based assessment)
Time frame: We will apply these instruments at T0 (baseline time), T1 (one day after the first session), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
This assessment will occur through the Genius game, which will evaluate the performance in the unit of measure of execution time (i.e. seconds) of the task.
Change from baseline executive function at 10 days of intervention (scale assessment)
Time frame: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
This assessment will occur through the Trail Making Test A and B, which provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. It requires the subject to connect encircled numbers randomly arranged on a page (Part A) and encircled numbers and letters in alternating order (Part B). Scoring is expressed in time in seconds required for completion of each of the two parts of the test. Scoring is expressed in terms of the time in seconds required for completion of each of the two parts of the test, on which the shorter the time to complete the task the better the performance (i.e part A < 180 s and part B < 300 s).
Change from baseline attention and executive function at 10 days of intervention (scale assessment)
Time frame: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
This assessment will occur through the Stroop Color and Word Test, which assesses the ease with which a person can maintain a goal in mind and suppress the habitual response in favor of a less familiar one (i.e selective attention and cognitive flexibility). Both the time to complete and the number of errors. In addition, the interference effect is determined by calculating the extra time required to name colors in the interference task in comparison to the time required to name colors in the control task.
Change from baseline processing speed at 10 days of intervention (scale assessment)
Time frame: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
This assessment will occur through the Code Search subtest (WAIS), which as evaluates the processing speed to complete a card with number and symbols that must be related to a correct execution of the test. The score is formulated based on correct answers. The maximum score is 133 points. The higher scores are related to better performance.
4 secondary outcomes
Change from baseline processing speed at 10 days of intervention (computer-based assessment)
Time frame: We will apply these instruments at T0 (baseline time), T1 (one day after the first session), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
Change from baseline reasoning and planning at 10 days of intervention (computer-based assessment)
Time frame: We will apply these instruments at T0 (baseline time), T1 (one day after the first session), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
Change from baseline quality of life at 10 days of intervention
Time frame: We will apply the QOLIBRI at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
Change from baseline depression at 10 days of intervention
Time frame: We will apply the BDI at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and and T3 (i.e after 1 month of follow-up time).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anodal tDCS and Computer-assisted training in people with Traumatic Brain Injury, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 8 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 5 Nov 2018. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Contact Amanda Vitória L de Araújo, Master (11971212653, amandavitooria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline working memory at 10 days of intervention (scale assessment) (time frame: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, i.e 10 days after the first session) and T3 (i.e after 1 month of follow-up time).). 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?
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 5 Nov 2018.