Traumatic Brain InjuryNCT01552473
Brain Training to Enhance Frontal Lobe Reasoning
A study testing Brain Training Program 1 and Brain Training Program 2 in people with Traumatic Brain Injury, run by The University of Texas at Dallas at 1 site in United States.
Trial summary
This study is being done to improve the ability to diagnose and to achieve higher-levels of functional recovery in soldiers and civilians who have suffered either mild Traumatic Brain Injury (TBIs) or moderate-to-severe TBIs at chronic stages of brain recovery (greater than 12 months). Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Brain Training Program 1 and Brain Training Program 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19-65 years of age
- Sustained a traumatic brain injury at least 6 months previously
- Comprehend simple instructions, perform tasks and take part in intervention
- Read, speak and comprehend English
- Participate in tasks involving motor abilities such as use of at least one arm or hand
Who cannot join
- Not proficient in reading, comprehending or speaking English
- Pre-existing Cerebral Palsy, Mental Retardation, Autism, Epilepsy, Schizophrenia, or Pervasive Developmental Disorder
- Individuals with Psychosis, Active Behavioral Disorder, or uncontrolled epilepsy
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Training to Enhance Frontal Lobe Reasoning in Soldiers and Civilian Adults With TBI
This study is being done to improve the ability to diagnose and to achieve higher-levels of functional recovery in soldiers and civilians who have suffered either mild Traumatic Brain Injury (TBIs) or moderate-to-severe TBIs at chronic stages of brain recovery (greater than 12 months).
Read the detailed description
In the current randomized control trial, we study the efficacy of a functionally relevant cognitive training program applied to individuals who are experiencing the effects of chronic TBI. The top-down training program labeled SMART (Strategic Memory Advanced Reasoning Training) adopts an integrative approach to train functionally relevant complex reasoning abilities (versus specific skills). This integrative approach focused on frontal lobe functions has shown promising results in a preliminary study. SMART is compared to an equally engaging education-based program labeled BHW (Brain Health Workshop). Both SMART and BHW are short-term, intensive (18 h of training over 8 weeks) group training programs that are comparable with regard to training time, amount of information, group discussions, and homework assignments. The overall goal of this trial is to examine how training integrative frontal lobe-mediated processes might improve functioning in brain injury survivors, including military service and civilian populations. We include a range of individuals with different injury types and functional abilities. We use a broad variety of assessment tools, including cognitive, neuroimaging, and functional measures, to compare the training groups.
Our overall goal is to improve the fidelity of TBI diagnoses and to achieve higher levels of functional recovery in soldiers and civilians who have suffered mild to moderate TBIs and are at the chronic stage of brain recovery. This study is also to determine the efficacy of an empirically and theoretically driven framework to enhance frontal lobe-mediated reasoning ability in individuals with TBI, given a relatively short training duration, on trained and untrained cognitive skills, on brain changes, and on measures of real-life function. Toward these aims, this trial is enrolling both soldiers and civilians with a TBI (approximately 50 mild and 50 moderate chronic TBI patients). We use cognitive tests (assessing memory, reasoning, and comprehension abilities), functional MRI scans (performing tests of cognitive function while the subject is receiving an MRI scan), and white matter maps constructed using diffusion tensor imaging (DTI) scans. The MRI scans will be used to provide biomarkers of the contributions of different brain regions to performing cognitive tasks (e.g., memory, reasoning, etc.), as well as assessments of brain efficiency, functional brain connectivity, and brain morphology. We use these measurements to gain an understanding of each individual's cognitive skills and neural measures prior to cognitive intervention. These measures also serve as indicators of the baseline function of each soldier or civilian, to be compared with after intervention, at which point they undergo post-training cognitive, MRI, and DTI assessments, enabling us to make outcome comparisons between the two different cognitive interventions. Finally, we conduct a follow-up assessment with neuropsychological and cognitive measures and neuroimaging 3 months after the interventions to assess how individuals maintain any functional changes that may occur because of the cognitive interventions.
We are targeting this intervention toward mild and moderate TBI participants, who have relatively high functioning skills. The demands of the training can be too high for some individuals falling into the more severe range, in the frequency, duration, and type of strategies and skills emphasized. We also aim to address the high level of need placed upon studies of milder TBI cases, particularly with military populations. This priority is also emphasized by the sponsoring agency, the US Department of Defense, advocating for more studies of mild TBI under the funding mechanism supporting this work.
- Conditions
- Traumatic Brain Injury
- Being tested
- Brain Training Program 1, Brain Training Program 2
- Keywords
- TBI, Traumatic Brain Injury, combat related injury, blast injury, concussion, sleep problems, attention problems, memory problems, headaches, dizziness, OEF, OIF, Veterans, Civilian
- Medical subject headings
- Brain Injuries, Traumatic, Blast Injuries, Brain Concussion, Parasomnias, Memory Disorders, Headache, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Training Program 1Behavioural
The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide information on brain injury and its recovery process. Activities involved in the sessions include discussion of study material. Participants will be encouraged to apply the information to their daily lives. The program includes additional outside practice of the activities.
Brain Training Program 2Behavioural
The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide strategies to improve brain injury and its recovery process. Activities involved in the sessions include strategies and discussion of study material. Participants will be encouraged to apply the strategies and information to their daily lives. The program includes additional outside practice of the activities.
| Study group | Role | What they receive |
|---|---|---|
| Brain Training Program 1 | Active comparator | Training Program focusing on providing educational information of cognitive issues related to TBI Receives: Behavioral: Brain Training Program 1 |
| Brain Training Program 2 | Experimental | Program focuses on strategies to address cognitive issues following TBI Receives: Behavioral: Brain Training Program 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale-Extended
Assesses disability after brain injury (1 dead to 8 good recovery). A higher score is a better outcome.
Measured: Pre-training (Baseline) Neuropsychological Test
Community Integration Questionnaire
To examine short-term effects of treatment on cognition and real-life outcomes relating to how successful someone is able to integrate within their community (0 lowest integration (worst outcome) to 40 maximal integration (best outcome)). A higher score is a better outcome.
Measured: Neuropsychological changes from baseline to 10 weeks post-training
Functional Status Exam
To examine short-term effects of treatment on outcomes. - (0 highest function (best outcome) to 31 lowest function (worst outcome)). A lower score is a better outcome.
Measured: Measure at 10 weeks post-training
Daneman-Carpenter Reading Span Test
Scored as 0 words to 7 words comprehended. Higher scores indicate better comprehension and thus a better outcome. Lower scores indicates a lower degree of comprehension. A higher score is a better outcome.
Measured: Measure at 10 weeks post-training
Hayling Sentence Completion Test
To examine short-term effects of treatment on cognition by working memory. The Hayling Sentence Completion test measures response initiation (range 0 best to 30 worst). A lower score is a better outcome.
Measured: Measure at 10 weeks post-training
Awareness Questionnaire
To examine short-term effects of treatment on real-life outcomes. This test measures impaired self-awareness after brain injury. The scale ranges from 17 (lowest self-awareness level, worst outcome) to 85 (highest self-awareness level, best outcome). A higher score is a better outcome.
Measured: Measure at 10 weeks post-training
Secondary outcomes (12)
Network Based Statistics in Brain Connectivity
Brain network connectivity from functional brain imaging was computed using Network-Based Statistics. Data were adjusted to form one number to characterize the significant connection changes associated with the training. This was accomplished by computing a change score. This change score combined the post-training (10 weeks), and 3-months post-training imaging data and compared that to the baseline (pre-training imaging data). This measure allows for an estimation of the number of statistically increased connections observed between different areas of the brain. A higher score indicates more significant connections and is considered to be a better outcome.
Measured: MRI measures taken at 10 weeks and 3 months post-training are combined and compared to baseline MRI yielding one number
Beck Depression Inventory (BDI)
To examine short-term effects of treatment on measures current depressive symptoms from 0 (no depressive symptoms (best outcome)) to 63 (maximum depressive symptoms (worst outcome)). A lower score is a better outcome.
Measured: Measure taken at 10 weeks post-training
Post Traumatic Stress Disorder (PTSD) Checklist
To examine short-term effects of treatment on self-reported measure of symptoms of posttraumatic stress disorder. The test ranges from 0 minimal stress symptoms to 80 maximum stress symptoms. A lower score is a better outcome.
Measured: Measure taken at 10 weeks post-training
Alcohol, Smoking and Substance Involvement Screening Test
To examine short-term effects of treatment on problem substance use. The range is from 0 low levels of problem substance use to 414 (maximum level of problem substance use). A lower score is a better outcome.
Measured: Measure taken at 10 weeks post-training
Alcohol Use Disorders Identification Test
To examine short-term effects of treatment on real-life outcomes on alcohol use disorder. The test ranges from 0 lowest use (best outcome) to 40 maximal use (worst outcome). A lower score is a better outcome.
Measured: Measure taken at 10 weeks post-training
Digit Vigilence Test
To examine short-term effects of treatment on attention. The test is scored as time in seconds with the lowest amount of time indicating the best performance. A lower score is a better outcome.
Measured: Measure taken at 10 weeks post-training
Connor-Davidson Resilience Scale
To examine short-term effects of treatment on resilience. the scores range from 0 (lowest reslience and worst outcome) to 100 (highest resilience and best outcome). A higher score is a better outcome.
Measured: Measure taken at 10 weeks post-training
Wechsler Memory Scale
To examine short-term effects of treatment on memory. The scores range from 0 (lowest memory level) to 20 (higher memory level). A higher score is a better outcome.
Measured: Measure taken at 10 weeks post-training
Wechsler Abbreviated Scale of Intelligence Vocabulary Scale
To examine short-term effects of treatment on vocabulary ability Score ranges from 20 (a lower level of vocabulary) to 80 (a higher level of vocabulary). A higher score is a better outcome.
Measured: Measure taken at 10 weeks post-training
Wechsler Abbreviated Scale of Intelligence Matrix Reasoning
To examine short-term effects of treatment on cognition with fluid reasoning being the measure ranging from 20 (lowest performance) to 80 (highest performance). A higher score is a better outcome.
Measured: Measure taken at 10 weeks post-training
Wechsler Abbreviated Scale of Intelligence Similarities
To examine short-term effects of treatment on cognition with a score of 20 indicating lowest similarities performance to 80 indicating the highest similarities performance. A higher score is a better outcome.
Measured: Measure taken at 10 weeks post-training
Satisfaction With Life Scale
To examine short-term effects of treatment on real-life outcomes. This ranges from 5 lowest satisfaction with life to 35 highest satisfaction with one's life. A higher score is a better outcome.
Measured: Measure taken at 10 weeks post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Dan Krawczyk, The University of Texas at Dallas
- Investigators
- Daniel Krawcyzk, Ph.D., Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552473
- Sponsor's protocol ID
- STU 032011-191
- Status last verified
- Feb 2025
- First submitted
- 6 Mar 2012
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Krawczyk DC, Marquez de la Plata C, Schauer GF, Vas AK, Keebler M, Tuthill S, Gardner C, Jantz T, Yu W, Chapman SB. Evaluating the effectiveness of reasoning training in military and civilian chronic traumatic brain injury patients: study protocol. Trials. 2013 Jan 30;14:29. doi: 10.1186/1745-6215-14-29.
PubMed 23363480
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Training to Enhance Frontal Lobe Reasoning in Soldiers and Civilian Adults With TBI
- ClinicalTrials.gov ID
- NCT01552473
- Acronym / sponsor ID
- STU 032011-191
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI, Traumatic Brain Injury, combat related injury, blast injury, concussion, sleep problems, attention problems, memory problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, Congressionally Directed Medical Research Programs
- Study start
- Mar 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Posted 10 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to improve the ability to diagnose and to achieve higher-levels of functional recovery in soldiers and civilians who have suffered either mild Traumatic Brain Injury (TBIs) or moderate-to-severe TBIs at chronic stages of brain recovery (greater than 12 months).
Detailed description
In the current randomized control trial, we study the efficacy of a functionally relevant cognitive training program applied to individuals who are experiencing the effects of chronic TBI. The top-down training program labeled SMART (Strategic Memory Advanced Reasoning Training) adopts an integrative approach to train functionally relevant complex reasoning abilities (versus specific skills). This integrative approach focused on frontal lobe functions has shown promising results in a preliminary study. SMART is compared to an equally engaging education-based program labeled BHW (Brain Health Workshop). Both SMART and BHW are short-term, intensive (18 h of training over 8 weeks) group training programs that are comparable with regard to training time, amount of information, group discussions, and homework assignments. The overall goal of this trial is to examine how training integrative frontal lobe-mediated processes might improve functioning in brain injury survivors, including military service and civilian populations. We include a range of individuals with different injury types and functional abilities. We use a broad variety of assessment tools, including cognitive, neuroimaging, and functional measures, to compare the training groups.
Our overall goal is to improve the fidelity of TBI diagnoses and to achieve higher levels of functional recovery in soldiers and civilians who have suffered mild to moderate TBIs and are at the chronic stage of brain recovery. This study is also to determine the efficacy of an empirically and theoretically driven framework to enhance frontal lobe-mediated reasoning ability in individuals with TBI, given a relatively short training duration, on trained and untrained cognitive skills, on brain changes, and on measures of real-life function. Toward these aims, this trial is enrolling both soldiers and civilians with a TBI (approximately 50 mild and 50 moderate chronic TBI patients). We use cognitive tests (assessing memory, reasoning, and comprehension abilities), functional MRI scans (performing tests of cognitive function while the subject is receiving an MRI scan), and white matter maps constructed using diffusion tensor imaging (DTI) scans. The MRI scans will be used to provide biomarkers of the contributions of different brain regions to performing cognitive tasks (e.g., memory, reasoning, etc.), as well as assessments of brain efficiency, functional brain connectivity, and brain morphology. We use these measurements to gain an understanding of each individual's cognitive skills and neural measures prior to cognitive intervention. These measures also serve as indicators of the baseline function of each soldier or civilian, to be compared with after intervention, at which point they undergo post-training cognitive, MRI, and DTI assessments, enabling us to make outcome comparisons between the two different cognitive interventions. Finally, we conduct a follow-up assessment with neuropsychological and cognitive measures and neuroimaging 3 months after the interventions to assess how individuals maintain any functional changes that may occur because of the cognitive interventions.
We are targeting this intervention toward mild and moderate TBI participants, who have relatively high functioning skills. The demands of the training can be too high for some individuals falling into the more severe range, in the frequency, duration, and type of strategies and skills emphasized. We also aim to address the high level of need placed upon studies of milder TBI cases, particularly with military populations. This priority is also emphasized by the sponsoring agency, the US Department of Defense, advocating for more studies of mild TBI under the funding mechanism supporting this work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain Training Program 1 | Active comparator | Behavioral: Brain Training Program 1Training Program focusing on providing educational information of cognitive issues related to TBI |
| Brain Training Program 2 | Experimental | Behavioral: Brain Training Program 2Program focuses on strategies to address cognitive issues following TBI |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 19-65 years of age
- Sustained a traumatic brain injury at least 6 months previously
- Comprehend simple instructions, perform tasks and take part in intervention
- Read, speak and comprehend English
- Participate in tasks involving motor abilities such as use of at least one arm or hand
Key exclusion criteria (4 listed)
- Not proficient in reading, comprehending or speaking English
- Pre-existing Cerebral Palsy, Mental Retardation, Autism, Epilepsy, Schizophrenia, or Pervasive Developmental Disorder
- Individuals with Psychosis, Active Behavioral Disorder, or uncontrolled epilepsy
- Women who are pregnant
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 |
|---|---|---|
| Brain Training Program 1The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide information on brain injury and its recovery process. Activities involved in the sessions include discussion of study material. Participants will be encouraged to apply the information to their daily lives. The program includes additional outside practice of the activities. | Behavioural | Brain Training Program 1 |
| Brain Training Program 2The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide strategies to improve brain injury and its recovery process. Activities involved in the sessions include strategies and discussion of study material. Participants will be encouraged to apply the strategies and information to their daily lives. The program includes additional outside practice of the activities. | Behavioural | Brain Training Program 2 |
Primary outcome
Glasgow Outcome Scale-Extended
Time frame: Pre-training (Baseline) Neuropsychological Test
Assesses disability after brain injury (1 dead to 8 good recovery). A higher score is a better outcome.
Community Integration Questionnaire
Time frame: Neuropsychological changes from baseline to 10 weeks post-training
To examine short-term effects of treatment on cognition and real-life outcomes relating to how successful someone is able to integrate within their community (0 lowest integration (worst outcome) to 40 maximal integration (best outcome)). A higher score is a better outcome.
Functional Status Exam
Time frame: Measure at 10 weeks post-training
To examine short-term effects of treatment on outcomes. - (0 highest function (best outcome) to 31 lowest function (worst outcome)). A lower score is a better outcome.
Daneman-Carpenter Reading Span Test
Time frame: Measure at 10 weeks post-training
Scored as 0 words to 7 words comprehended. Higher scores indicate better comprehension and thus a better outcome. Lower scores indicates a lower degree of comprehension. A higher score is a better outcome.
Hayling Sentence Completion Test
Time frame: Measure at 10 weeks post-training
To examine short-term effects of treatment on cognition by working memory. The Hayling Sentence Completion test measures response initiation (range 0 best to 30 worst). A lower score is a better outcome.
Awareness Questionnaire
Time frame: Measure at 10 weeks post-training
To examine short-term effects of treatment on real-life outcomes. This test measures impaired self-awareness after brain injury. The scale ranges from 17 (lowest self-awareness level, worst outcome) to 85 (highest self-awareness level, best outcome). A higher score is a better outcome.
12 secondary outcomes
Network Based Statistics in Brain Connectivity
Time frame: MRI measures taken at 10 weeks and 3 months post-training are combined and compared to baseline MRI yielding one number
Beck Depression Inventory (BDI)
Time frame: Measure taken at 10 weeks post-training
Post Traumatic Stress Disorder (PTSD) Checklist
Time frame: Measure taken at 10 weeks post-training
Alcohol, Smoking and Substance Involvement Screening Test
Time frame: Measure taken at 10 weeks post-training
Alcohol Use Disorders Identification Test
Time frame: Measure taken at 10 weeks post-training
Digit Vigilence Test
Time frame: Measure taken at 10 weeks post-training
Connor-Davidson Resilience Scale
Time frame: Measure taken at 10 weeks post-training
Wechsler Memory Scale
Time frame: Measure taken at 10 weeks post-training
Wechsler Abbreviated Scale of Intelligence Vocabulary Scale
Time frame: Measure taken at 10 weeks post-training
Wechsler Abbreviated Scale of Intelligence Matrix Reasoning
Time frame: Measure taken at 10 weeks post-training
Wechsler Abbreviated Scale of Intelligence Similarities
Time frame: Measure taken at 10 weeks post-training
Satisfaction With Life Scale
Time frame: Measure taken at 10 weeks post-training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23363480Krawczyk DC, Marquez de la Plata C, Schauer GF, Vas AK, Keebler M, Tuthill S, Gardner C, Jantz T, Yu W, Chapman SB. Evaluating the effectiveness of reasoning training in military and civilian chronic traumatic brain injury patients: study protocol. Trials. 2013 Jan 30;14:29. doi: 10.1186/1745-6215-14-29.
- Center for BrainHealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Daniel Krawcyzk, Ph.D. principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Training Program 1 and Brain Training Program 2 in people with Traumatic Brain Injury, run by The University of Texas at Dallas at 1 site in United States.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 10 Mar 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glasgow Outcome Scale-Extended (time frame: Pre-training (Baseline) Neuropsychological Test). The study lists 6 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 NCT01552473, 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 10 Mar 2025.