Brain InjuryNCT01120756
Neural Bases of Cognitive Rehabilitation for Brain Injury
A study testing Goal-oriented attentional self-regulation and Brain Health Education in people with Brain Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Some of the most common and disabling consequences of brain injury are deficits in cognition, such as difficulty with sustained attention, memory, organization, and goal management. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injury
- What is being tested?
- Goal-oriented attentional self-regulation and Brain Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2011to 29 Dec 2018
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with a history of TBI (reported plausible mechanism of head injury, loss of consciousness with some period of post-traumatic alteration in cognition) who are > 6 months post-injury will be screened for evidence of mild-moderate residual dysfunction in executive control functions based on corroborated reports of real-world difficulties (Mayo-Portland Adaptability Inventory).
Who cannot join
- Severely apathetic/abulic
- aphasic
- or other reasons for patients being unable or unwilling to participate with the training tasks
- severe cognitive dysfunction
- history of neurodevelopmental abnormalities
- ongoing illicit drug or alcohol abuse (AUDIT>8)
Show all 9Show fewer
- severe depression as measured by Beck Depression Inventory (>29)
- severe PTSD precluding participation in research activities (such as group training or MRI scanning)
- There will be no restriction in regard to gender, race and socioeconomic status.
Trial locations and contacts
1 site in 1 country.
United States1 site
Martinez Outpatient Clinic and Community Living Center, Martinez, CA
Martinez, California, 94553
About this study
Some of the most common and disabling consequences of brain injury are deficits in cognition, such as difficulty with sustained attention, memory, organization, and goal management. The long-term goal of this research program is to develop and test novel neuroscience-based cognitive interventions for improving attentional regulation and related "executive function" brain processes involved in goal-directed behavior.
Read the detailed description
Brain injury often results in a disruption of attention regulation processes, which reduces the efficiency and effectiveness of cognitive functions including learning, memory, problem-solving and goal management, leading to significant functional disability. More intervention options are needed.
We set out to test different possible interventions. Individuals with traumatic brain injury (TBI) and chronic executive control dysfunction participate in interventions, with pre- and post-intervention measurements of cognitive functioning. Training in Goal-oriented attentional self-regulation (GOALS) was administered in comparison to Brain Health Education (EDU).
GOALS is designed to train attention regulation skills along with meta-cognitive strategies for goal management, with a emphasis on application to participant-selected projects. This is a group-based intervention.
Brain Health Education is designed to increase knowledge and understanding of key factors that affect brain functioning. This is a group-based intervention matched to the GOALS intervention.
- Conditions
- Brain Injury
- Being tested
- Goal-oriented attentional self-regulation, Brain Health Education
- Keywords
- executive dysfunction, brain injury, attention, rehabilitation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-oriented attentional self-regulationBehavioural
This will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). In brief, the GBSM training protocol is designed to maximize the potential for improving attention regulation skills and the goal-directed functions they support, applying mindfulness-based attention regulation training to practice in redirecting attention to goal-relevant processes especially in the context of distractions is emphasized throughout training. Participants are asked to identify realistic functional goals as feasible individual and group projects, and are then trained in goal management strategies on the functional task(s) of their choice.
Brain Health EducationBehavioural
Brain Health Education (EDU) will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education in health and brain injury in a classroom format, with study materials for homework.
| Study group | Role | What they receive |
|---|---|---|
| Goal-oriented attentional self-regulation training | Experimental | Goal-oriented attentional self-regulation training (GOALS). Receives: Behavioral: Goal-oriented attentional self-regulation |
| Brain Health Education | Active comparator | Brain Health Education (EDU) Receives: Behavioral: Brain Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on a Composite Measure (Z-score) of Attention, Working Memory, and Executive Functions
We computed a composite measure based upon the average of individuals' scores on commonly used neuropsychological tests of attention, working memory, and executive functions. To compute this composite score, we first scored individual performances on each neuropsychological measure utilizing published norms, adjusted for, when available, age, gender, ethnicity, and education levels. We then converted all resultant scores (e.g., T-scores, Standard Scores) to a common metric, z-scores. (Z-scores are a standardized unit of measurement, scaled in terms of standard deviation (SD) units. Thus, a z-score of 0 represents the mean; a z-score of 1 represents+1 SD above the mean; and a z-score of -1 represents -1 SD below the mean.) Finally, for each participant, z-scores derived from each separate neuropsychological test were averaged together to yield a final composite score. The composite score was the unit of analysis.
Measured: Baseline, Within 2-3 weeks Post-intervention
Secondary outcomes (1)
Functional Evaluations: Change From Baseline on the Goal Processing Scale
Observed measures of functional performance on complex tasks were assessed for the GOALS and Brain Health Education study. The overall composite score comprises scores for planning, initiation, self-monitoring, maintenance of attention, sequencing and switching, divergent thinking, execution, learning and memory. Scores range from 1-10. Changes were calculated from pre-to post-training, and higher scores indicate improvement in functioning.
Measured: Baseline, 2-3 Weeks Post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study start1 Oct 2011
- Primary completion30 May 2018
- Study completion29 Dec 2018
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 Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of California, Berkeley
- Responsible party
- Sponsor
- Investigators
- Anthony Chen, MD MA, Principal investigator, Martinez Outpatient Clinic, Martinez, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120756
- Sponsor's protocol ID
- B7467-I
- Status last verified
- Jun 2019
- First submitted
- 7 May 2010
- Last updated
- 2 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Novakovic-Agopian T, Kornblith E, Abrams G, Burciaga-Rosales J, Loya F, D'Esposito M, Chen AJW. Training in Goal-Oriented Attention Self-Regulation Improves Executive Functioning in Veterans with Chronic Traumatic Brain Injury. J Neurotrauma. 2018 Dec 1;35(23):2784-2795. doi: 10.1089/neu.2017.5529. Epub 2018 Jul 23.
PubMed 29717652
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Bases of Cognitive Rehabilitation for Brain Injury
- ClinicalTrials.gov ID
- NCT01120756
- Acronym / sponsor ID
- B7467-I
- Conditions
- Brain Injury
- Keywords
- executive dysfunction, brain injury, attention, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of California, Berkeley
- Study start
- 1 Oct 2011 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 29 Dec 2018 (actual)
- First posted
- 11 May 2010 (estimated)
- Results
- Posted 2 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some of the most common and disabling consequences of brain injury are deficits in cognition, such as difficulty with sustained attention, memory, organization, and goal management. The long-term goal of this research program is to develop and test novel neuroscience-based cognitive interventions for improving attentional regulation and related "executive function" brain processes involved in goal-directed behavior.
Detailed description
Brain injury often results in a disruption of attention regulation processes, which reduces the efficiency and effectiveness of cognitive functions including learning, memory, problem-solving and goal management, leading to significant functional disability. More intervention options are needed.
We set out to test different possible interventions. Individuals with traumatic brain injury (TBI) and chronic executive control dysfunction participate in interventions, with pre- and post-intervention measurements of cognitive functioning. Training in Goal-oriented attentional self-regulation (GOALS) was administered in comparison to Brain Health Education (EDU).
GOALS is designed to train attention regulation skills along with meta-cognitive strategies for goal management, with a emphasis on application to participant-selected projects. This is a group-based intervention.
Brain Health Education is designed to increase knowledge and understanding of key factors that affect brain functioning. This is a group-based intervention matched to the GOALS intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal-oriented attentional self-regulation training | Experimental | Behavioral: Goal-oriented attentional self-regulationGoal-oriented attentional self-regulation training (GOALS). |
| Brain Health Education | Active comparator | Behavioral: Brain Health EducationBrain Health Education (EDU) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with a history of TBI (reported plausible mechanism of head injury, loss of consciousness with some period of post-traumatic alteration in cognition) who are > 6 months post-injury will be screened for evidence of mild-moderate residual dysfunction in executive control functions based on corroborated reports of real-world difficulties (Mayo-Portland Adaptability Inventory).
Key exclusion criteria (9 listed)
- Severely apathetic/abulic
- aphasic
- or other reasons for patients being unable or unwilling to participate with the training tasks
- severe cognitive dysfunction
- history of neurodevelopmental abnormalities
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 |
|---|---|---|
| Goal-oriented attentional self-regulationThis will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). In brief, the GBSM training protocol is designed to maximize the potential for improving attention regulation skills and the goal-directed functions they support, applying mindfulness-based attention regulation training to practice in redirecting attention to goal-relevant processes especially in the context of distractions is emphasized throughout training. Participants are asked to identify realistic functional goals as feasible individual and group projects, and are then trained in goal management strategies on the functional task(s) of their choice. | Behavioural | Goal-oriented attentional self-regulation training |
| Brain Health EducationBrain Health Education (EDU) will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education in health and brain injury in a classroom format, with study materials for homework. | Behavioural | Brain Health Education |
Primary outcome
Change From Baseline on a Composite Measure (Z-score) of Attention, Working Memory, and Executive Functions
Time frame: Baseline, Within 2-3 weeks Post-intervention
We computed a composite measure based upon the average of individuals' scores on commonly used neuropsychological tests of attention, working memory, and executive functions. To compute this composite score, we first scored individual performances on each neuropsychological measure utilizing published norms, adjusted for, when available, age, gender, ethnicity, and education levels. We then converted all resultant scores (e.g., T-scores, Standard Scores) to a common metric, z-scores. (Z-scores are a standardized unit of measurement, scaled in terms of standard deviation (SD) units. Thus, a z-score of 0 represents the mean; a z-score of 1 represents+1 SD above the mean; and a z-score of -1 represents -1 SD below the mean.) Finally, for each participant, z-scores derived from each separate neuropsychological test were averaged together to yield a final composite score. The composite score was the unit of analysis.
1 secondary outcome
Functional Evaluations: Change From Baseline on the Goal Processing Scale
Time frame: Baseline, 2-3 Weeks Post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29717652Novakovic-Agopian T, Kornblith E, Abrams G, Burciaga-Rosales J, Loya F, D'Esposito M, Chen AJW. Training in Goal-Oriented Attention Self-Regulation Improves Executive Functioning in Veterans with Chronic Traumatic Brain Injury. J Neurotrauma. 2018 Dec 1;35(23):2784-2795. doi: 10.1089/neu.2017.5529. Epub 2018 Jul 23.
- 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.
Anthony Chen, MD MA principal investigator
Martinez Outpatient Clinic, Martinez, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-oriented attentional self-regulation and Brain Health Education in people with Brain Injury, run by VA Office of Research and Development 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 1 inclusion and 9 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 2 Aug 2019. 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 2 Aug 2019). 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?
Change From Baseline on a Composite Measure (Z-score) of Attention, Working Memory, and Executive Functions (time frame: Baseline, Within 2-3 weeks Post-intervention). 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 NCT01120756, 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 2 Aug 2019.