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Fatigue, Sleep Disorders and Endocrine Abnormalities in TBI Patients

The Relationship Between Fatigue, Sleep Disorders and Endocrine Abnormalities Following Traumatic Brain Injury

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00775775
Enrollment
50
Registered
2008-10-20
Start date
2003-05-31
Completion date
2009-12-31
Last updated
2009-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

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.

Interventions

None listed

Sponsors

Kessler Foundation
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
To further study the incidence of fatigue and endocrine abnormalities in an outpatient TBI population1 year

Secondary

MeasureTime frame
To study the relationship between fatigue and endocrine abnormalities1 year

Countries

United States

Contacts

Primary ContactAnthony Lequerica, Ph.D.
alequerica@kesslerfoundation.net973-324-3551
Backup ContactAlexandria Muench
amuench@kesslerfoundation.net973-324-3540

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026