Validation of Brief Objective Neurobehavioral Detectors (BOND) in Mild TBI
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The Veterans Health Administration (VHA) has stated the need for a brief screening instrument that can assist with the triage of the enormous number of returning OEF/OIF veterans with concussion. The investigators combined selected neurological and brief cognitive tests to develop an instrument called, "Brief Objective Neurobehavioral Detectors" (BOND). The BOND takes only 15-20 minutes to administer with immediate results. In a previous study, the BOND was able to predict periventricular white matter disease (PWMD) visible on MRI scans with 91% sensitivity and 76% specificity. Thus, the BOND has shown sensitivity to, and specificity for, white matter abnormalities. Given that white matter abnormalities are the most common type of injury in mTBI, it is probable that the BOND could be sensitive to traumatic axonal injury (TAI) in TBI. Advanced neuroimaging measures, such as diffusion tensor imaging, will be used to help validate the BOND. If validated as a screening tool for OEF/OIF veterans with concussion, the BOND could reduce evaluation and associated waiting times and accelerate the initiation of treatment or case management. These benefits would be expected to increase veteran quality of life and satisfaction with care.
| Condition |
|---|
|
Brain Concussion |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Validation of Brief Objective Neurobehavioral Detectors of Mild TBI |
- Total Score: Brief Objective Neurobehavioral Evaluation (BOND) [ Time Frame: At single evaluation visit ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Group 1
Validation study of screening instrument.
|
Detailed Description:
As of November 2012, 75 of the 100 planned sample have been recruited and evaluated. Recruitment and enrollment is continuing.
Eligibility| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
OEF/OIF veterans with and without mTBI
Inclusion Criteria:
Inclusion criteria for mTBI Group (Case Group):
mTBI group veterans must:
- be enrolled at the Washington, DC VAMC
- be an OEF/OIF veteran
- be between the ages of 18 and 59, inclusive
- have at least 10 years of education
- be able to fit into scanner (i.e., weigh less than 400 pounds)
- have a mild brain injury (based upon VHA criteria)
- have a brain injury related to blast exposure
- be at least one year post-injury
Inclusion criteria for NonTBI Group (Control Group):
NonTBI group veterans must:
- be enrolled at the Washington, DC VAMC
- be between the ages of 18 and 59, inclusive
- have at least 10 years of education
Exclusion Criteria:
Exclusion Criteria for both the Case and Control Groups:
Veterans must NOT:
- be colorblind or have any visual impairment that interferes with reading or writing
- have any upper extremity dysfunction that prevents the use of a pencil or computer mouse or keyboard
- meet criteria for substance dependence within 1 month of the evaluation
- have had a period of two or more years in the past during which criteria for substance dependence was met
- have a current acute or unstable psychiatric condition
- have a current diagnosis (or symptoms consistent with) schizophrenic or bipolar disorders, or severe uni-polar depression
- be in significant pain during the evaluation (patient subjective report)
- have a diagnosis of diabetes (PET imaging considerations)
- have had or currently have any other injury, medical or neurological illness, or exposure that could potentially explain cognitive deficits (e.g., CNS disease, prior brain injury, seizure disorder, or HIV)
- be taking prescription drugs that significantly interfere with outcome measures
- have any devices or material implanted, embedded, or attached to the body containing ferrous material that interferes with MR imaging (i.e., pacemaker, shrapnel)
- Be a pregnant or lactating female (MRI considerations)
- Display behavior that would significantly interfere with validity of data collection or safety during study
Contacts and Locations| Contact: Lauren Roselli | (202) 745-8000 ext 7553 | Chapman.Research@va.gov |
| Contact: Julie C Chapman | (202) 745-8000 ext 6207 | julie.chapman@va.gov |
| United States, District of Columbia | |
| VA Medical Center, DC | Recruiting |
| Washington, District of Columbia, United States, 20422 | |
| Contact: Lauren Roselli 202-745-8000 ext 7553 Chapman.Research@va.gov | |
| Principal Investigator: Julie C. Chapman | |
| Principal Investigator: | Julie C. Chapman | VA Medical Center, DC |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00724607 History of Changes |
| Other Study ID Numbers: | SHP 08-167, 01133 |
| Study First Received: | July 23, 2008 |
| Last Updated: | November 21, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Brain Concussion Screening instrument Diffusion Tensor Imaging |
Additional relevant MeSH terms:
|
Brain Concussion Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Head Injuries, Closed Wounds and Injuries Wounds, Nonpenetrating |
ClinicalTrials.gov processed this record on May 19, 2013