Fatigue and Endocrine Abnormalities in TBI Patients

This study is ongoing, but not recruiting participants.

Sponsored by:	Kessler Medical Rehabilitation Research Center
Information provided by:	Kessler Medical Rehabilitation Research Center
ClinicalTrials.gov Identifier:	NCT00775775

Purpose

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.

Condition
Traumatic Brain Injury

MedlinePlus related topics: Rehabilitation Traumatic Brain Injury

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	The Relationship Between Fatigue and Endocrine Abnormalities Following Traumatic Brain Injury

Further study details as provided by Kessler Medical Rehabilitation Research Center:

Primary Outcome Measures:

To further study the incidence of fatigue and endocrine abnormalities in an outpatient TBI population [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To study the relationship between fatigue and endocrine abnormalities [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	May 2003
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
TBI Patients with moderate to severe TBI

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The study will consist of 50 participants taken from the outpatient brain injury program at Kessler.

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775775

Locations

United States, New Jersey
Kessler Medical Rehabilitation Research and Education Center
West Orange, New Jersey, United States, 07052

Sponsors and Collaborators

Kessler Medical Rehabilitation Research Center

Investigators

Principal Investigator:

Elie P Elovic, M.D.

Kessler Medical Rehabilitation Research Center

More Information

Responsible Party:	Kessler Medical Rehabilitation Research and Education Center ( Elie Elovic, M.D. )
Study ID Numbers:	R45303
Study First Received:	October 16, 2008
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00775775
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Craniocerebral Trauma
Fatigue
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Trauma, Nervous System
Brain Diseases
Congenital Abnormalities
Brain Injuries

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009