Traumatic Brain InjuryNCT02366442
Exploring Relationships Among Balance Performance, Cognitive Dysfunction, Affective Dysregulation, and Community Integration in Veterans With Traumatic Brain Injury (TBI)
An observational study of Traumatic Brain Injury and TBI, run by Washington D.C. Veterans Affairs Medical Center.
Trial summary
The overarching goal of the proposed study, named SYNERGY, is to explore relationships among balance performance, cognitive function, affective dysregulation, as they relate to the community re-integration in Veterans with TBI. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury, TBI
- What is being tested?
- Exploring relationships among balance performance, cognitive dysfunction, affective dysregulation, and community integration in Veterans with Traumatic Brain Injury (TBI).
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Oct 2015
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans with the diagnosis of TBI
Exclusion-inclusion criteria Inclusion Criteria: Enrolled participants will be Veterans with TBI between18 to55 years of age. We identified a wide age range in order to include Veterans from the Iraq and Afghanistan conflicts, as well as Veterans of the Vietnam War. This feature of the inclusion criteria is important since barriers to community re-integration may be affected by impaired balance, cognitive dysfunction, affective dysregulation, across the age spectrum. Consequently, the study findings will potentially benefit not only young Veterans, but also middle aged Veterans.
The Military Acute Concussion Evaluation (MACE): We will use MACE scores of 21/30 to ensure the participants have the cognitive ability to understand our study protocol, and therefore, participate voluntarily in the study. 62 Exclusion Criteria: We will use an exclusion criteria of 12/24 on the Dynamic gait index (DGI) to ensure that patients are ambulatory either with or without the use of assistive device to be able to measure dynamic balance accurately.16 Past Medical History: The following diagnoses will be cause for exclusion -- peripheral neuropathy, Parkinson syndromes, multiple sclerosis; bipolar, schizophrenia, seizure or psychiatric illnesses.
Medically stable patients: It is essential to minimize future medical adverse conditions and minimize the risk of drop out. Therefore, no patient shall be considered for enrollment if they do not meet inclusion/exclusion criteria or have not been recommended by the polytrauma staff at VA DCMC.
The result of VHA TBI Comprehensive Evaluation electronic template will be reviewed following IRB approved and HIPAA compliant data collection procedures. The TBI diagnosis will be obtained from patient's chart review of problem section and physician's notes.
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About this study
The overarching goal of the proposed study, named SYNERGY, is to explore relationships among balance performance, cognitive function, affective dysregulation, as they relate to the community re-integration in Veterans with TBI. The SYNERGY study findings can aid in the development of a better outcome models for the clinicians in facilitating effective community re-integration in Veterans with TBI
Read the detailed description
Examine if there are associations among balance, cognitive and affective function during multitasking activities in Veterans with the diagnosis of TBI.
To determine if an association exists between balance performance and the degree of community re-integration in Veterans with TBI.
To determine which of the three systems, balance performance, cognitive dysfunction or affective dysregulation, is the strongest predictor of community re-integration in Veterans with TBI.
- Conditions
- Traumatic Brain Injury, TBI
- Being tested
- Exploring relationships among balance performance, cognitive dysfunction, affective dysregulation, and community integration in Veterans with Traumatic Brain Injury (TBI).
- Keywords
- dual/multitasking, Executive function, Affective function, Balance
- 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.
Exploring relationships among balance performance, cognitive dysfunction, affective dysregulation, and community integration in Veterans with Traumatic Brain Injury (TBI).Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploring relationships among balance performance, cognitive dysfunction, affective dysregulation, and community integration in Veterans with Traumatic Brain Injury (TBI).
Measured: 1-2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington D.C. Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dr. Azadeh M. Leland, Washington D.C. Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366442
- Sponsor's protocol ID
- WashingtonVAMC
- Status last verified
- Feb 2015
- First submitted
- 11 Feb 2015
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Relationships Among Balance Performance, Cognitive Dysfunction, Affective Dysregulation, and Community Integration in Veterans With Traumatic Brain Injury (TBI)
- ClinicalTrials.gov ID
- NCT02366442
- Acronym / sponsor ID
- WashingtonVAMC
- Conditions
- Traumatic Brain Injury, TBI
- Keywords
- dual/multitasking, Executive function, Affective function, Balance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Washington D.C. Veterans Affairs Medical CenterUS federal agency
- Study start
- Feb 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 19 Feb 2015 (estimated)
- 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.
The overarching goal of the proposed study, named SYNERGY, is to explore relationships among balance performance, cognitive function, affective dysregulation, as they relate to the community re-integration in Veterans with TBI. The SYNERGY study findings can aid in the development of a better outcome models for the clinicians in facilitating effective community re-integration in Veterans with TBI
Detailed description
Examine if there are associations among balance, cognitive and affective function during multitasking activities in Veterans with the diagnosis of TBI.
To determine if an association exists between balance performance and the degree of community re-integration in Veterans with TBI.
To determine which of the three systems, balance performance, cognitive dysfunction or affective dysregulation, is the strongest predictor of community re-integration in Veterans with TBI.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans with the diagnosis of 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 |
|---|---|---|
| Exploring relationships among balance performance, cognitive dysfunction, affective dysregulation, and community integration in Veterans with Traumatic Brain Injury (TBI). | Other | – |
Primary outcome
Exploring relationships among balance performance, cognitive dysfunction, affective dysregulation, and community integration in Veterans with Traumatic Brain Injury (TBI).
Time frame: 1-2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and TBI, run by Washington D.C. Veterans Affairs Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Exploring relationships among balance performance, cognitive dysfunction, affective dysregulation, and community integration in Veterans with Traumatic Brain Injury (TBI). (time frame: 1-2 year). 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 19 Feb 2015.