Fatigue, Sleep Disorders and Endocrine Abnormalities in TBI Patients
- Conditions
- Traumatic Brain Injury
- Registration Number
- NCT00775775
- Lead Sponsor
- Kessler Foundation
- Brief Summary
This study will test if patients with moderate to severe traumatic brain injuries also have endocrine abnormalities, examine any existing relationships among fatigue, depression and endocrine abnormalities, and the relationship between endocrine abnormalities, quality of life, and community integration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Having moderate to severe TBI at least 3 months prior to enrollment. This can be demonstrated by a history of loss of consciousness, amnesia or another neurologic deficit after brain injury
- Be between the ages of 18 and 70 years
Exclusion Criteria
- History of prior TBI, stroke, seizures, severe psychiatric disturbances (i.e., those known to influence memory performance, such as schizophrenia, bipolar disorder), or drug abuse will be excluded.
- Pregnant, nursing, or planning pregnancy during the study period.
- Dementia
- Other neurological conditions which are associated with aging and known to cause fatigue (e.g. Parkinson's Disease)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To further study the incidence of fatigue and endocrine abnormalities in an outpatient TBI population 1 year
- Secondary Outcome Measures
Name Time Method To study the relationship between fatigue and endocrine abnormalities 1 year
Trial Locations
- Locations (1)
Kessler Foundation Research Center
🇺🇸West Orange, New Jersey, United States