Fatigue, Sleep Disorders and Endocrine Abnormalities in TBI Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00775775
Recruitment Status : Unknown
Verified October 2009 by Kessler Foundation.
Recruitment status was:  Recruiting
First Posted : October 20, 2008
Last Update Posted : October 6, 2009
Information provided by:
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.

Condition or disease
Traumatic Brain Injury

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Relationship Between Fatigue, Sleep Disorders and Endocrine Abnormalities Following Traumatic Brain Injury
Study Start Date : May 2003
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Patients with moderate to severe TBI

Primary Outcome Measures :
  1. To further study the incidence of fatigue and endocrine abnormalities in an outpatient TBI population [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To study the relationship between fatigue and endocrine abnormalities [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00775775

Contact: Anthony Lequerica, Ph.D. 973-324-3551
Contact: Alexandria Muench 973-324-3540

United States, New Jersey
Kessler Foundation Research Center Recruiting
West Orange, New Jersey, United States, 07052
Contact: Anthony Lequerica, Ph.D.    973-324-3551   
Contact: Alexandria Muench    973-324-3540   
Sponsors and Collaborators
Kessler Foundation
Principal Investigator: Anthony Lequerica, Ph.D. Kessler Foundation

Responsible Party: Anthony Lequerica, Ph.D., Kessler Foundation Research Center Identifier: NCT00775775     History of Changes
Other Study ID Numbers: R45303
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: October 6, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Sleep Wake Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Signs and Symptoms
Neurologic Manifestations
Mental Disorders