Protocol Details
Evaluation and Diagnosis of Potential Research Subjects with Traumatic Brain Injury (TBI)
This study is NOT currently recruiting participants.
Summary
Number |
11-N-0084 |
Sponsoring Institute |
National Institute of Neurological Disorders and Stroke (NINDS) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: N/A |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Keywords |
Recruitment;
TBI;
Screening;
Traumatic Brain Injury |
Recruitment Keyword(s) |
Traumatic Brain Injury;
TBI |
Condition(s) |
Traumatic Brain Injury |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute of Neurological Disorders and StrokeCenter for Neuroscience and Regenerative Medicine (CNRM) |
Background:
- 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.
Objectives:
- To develop a pool of individuals with traumatic brain injury and post-concussive syndrome for future research studies.
Eligibility:
- 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.
Design:
- Participants will be screened with an initial telephone interview, and will be asked to come to the National Institutes of Health for an in-person screening visit.
- At the screening visit, participants will provide a medical history, have a physical examination and complete a study questionnaire on their TBI and its symptoms, including how the injury occurred, when it occurred, and any previous brain-related injuries.
-Subjects may also return for a second visit at the NIH CC if eligible.
-Each visit may involve blood samples, an MRI scan, and a series of tests to evaluate brain function.
- Participants will also provide contact information to enable researchers to contact them for future studies.
Eligibility
INCLUSION CRITERIA:
To be included, participants must meet all of the following:
-Age greater than or equal to 18 years of age
-Report having symptoms or diagnosis of concussion, TBI, post concussional syndrome, or post concussional disorder.
-Are able to provide informed consent or, have a legally authorized representative (LAR) provide consent.
-Are willing to have their contact information and data shared and stored by the CNRM for referral to current and future CNRM studies
EXCLUSION CRITERIA:
-Are unwilling or unable to cooperate with the study procedures
Citations:
Rutland-Brown W, Langlois JA, Thomas KE, Xi YL. Incidence of traumatic brain injury in the United States, 2003. J Head Trauma Rehabil. 2006 Nov-Dec;21(6):544-8.
Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8.
Kraus MF, Smith GS, Butters M, Donnell AJ, Dixon E, Yilong C, Marion D. Effects of the dopaminergic agent and NMDA receptor antagonist amantadine on cognitive function, cerebral glucose metabolism and D2 receptor availability in chronic traumatic brain injury: a study using positron emission tomography (PET). Brain Inj. 2005 Jul;19(7):471-9.
Contacts:
Clinical Trials Number:
NCT01287156