Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury
|First Received Date ICMJE||January 29, 2011|
|Last Updated Date||August 12, 2017|
|Start Date ICMJE||January 13, 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To facilitate patient recruitment to CNRM sponsored TBI related clinical research at the NIH and participating CNRM sites by developing a patient recruitment database [ Time Frame: At least monthly, as appropriate ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01287156 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||To evaluate the effectiveness of the recruitment methods utilized in this protocol and determine the most successful outreach approaches and recruitment tools for the recruitment and enrollment of TBI study participants [ Time Frame: Annually, or as needed ad hoc ]|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury|
|Official Title ICMJE||Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury (TBI)|
- The Center for Neuroscience and Regenerative Medicine is working to improve physicians' understanding of brain injury. More information is needed on traumatic brain injury (TBI), especially how well a person recovers from TBI and how the brain changes over time in people with TBI. To conduct this research, the center is sponsoring a number of research studies on TBI and is interested in evaluating individuals with TBI or post-concussive syndrome to determine if they might be eligible for future studies.
- To develop a pool of individuals with traumatic brain injury and post-concussive syndrome for future research studies.
- Individuals at least 18 years of age who have symptoms of or have been diagnosed with traumatic brain injury or post-concussive syndrome and are willing to participate in future studies.
This screening and registry protocol is designed to facilitate subject recruitment for the Center for Neuroscience and Regenerative Medicine (CNRM) sponsored clinical research studies on traumatic brain injury (TBI) at the National Institutes of Health (NIH) and participating CNRM sites. This protocol will serve as a first step for evaluating subjects for possible inclusion in CNRM sponsored natural history, observational, or interventional protocols. Other approved CNRM protocols may continue to recruit subjects directly into their respective studies, and may refer subjects to this study.
The objective of this protocol is to develop a subject recruitment database that will house preliminary data on research subjects who are interested in and potentially eligible for current and future CNRM sponsored protocols. The effectiveness of the recruitment methods utilized in this protocol will be evaluated to determine the most successful outreach approaches and recruitment tools for the enrollment of TBI or post concussive study subjects.
This protocol will enroll 2500 male and female adult subjects with signs/symptoms or diagnosis of TBI or post-concussive syndrome, from participating sites, other CNRM sponsored protocols and within the community using various methods of outreach and advertisement.
This study involves an initial study visit conducted in one of two ways: at the NIH Clinical Center,or at the participating site. Subjects enrolled acutely and/or at a participating site may also be provided the option to complete an additional visit at the NIH CC after their initial visit. Based on the information obtained during the initial study visit, the subject will be referred to appropriate CNRM protocols for further protocol-specific screening prior to enrollment, or informed that s/he is not eligible for any other actively enrolling CNRM studies at this time. Study procedures may include: physical exam, medical history, nursing evaluation, questionnaires completed by interview, blood and urine sample collection, and magnetic resonance imaging (MRI).
Follow-up visits will be conducted by telephone at regular intervals for a year, and then ad hoc at potential referral eligibility to update contact information and collect outcome data. No treatment is offered under this protocol.
The outcome measures include accrual of subjects, retention of enrolled subjects and loss to follow-up, and referral number and rate of enrolled subjects to other CNRM studies. In addition, we will evaluate the frequency and certainty of injury classification (possible, probable, or definite TBI).
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case-Only
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Traumatic Brain Injury|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||2500|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
To be included, participants must meet all of the following:
-Are unwilling or unable to cooperate with the study procedures
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01287156|
|Other Study ID Numbers ICMJE||110084
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )|
|Study Sponsor ICMJE||National Institute of Nursing Research (NINR)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 11, 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP