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Fatigue, Sleep Disorders and Endocrine Abnormalities in TBI Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Kessler Foundation.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00775775
First Posted: October 20, 2008
Last Update Posted: October 6, 2009
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.
Information provided by:
Kessler Foundation
  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

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

Resource links provided by NLM:


Further study details as provided by Kessler Foundation:

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
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
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 ClinicalTrials.gov identifier (NCT number): NCT00775775


Contacts
Contact: Anthony Lequerica, Ph.D. 973-324-3551 alequerica@kesslerfoundation.net
Contact: Alexandria Muench 973-324-3540 amuench@kesslerfoundation.net

Locations
United States, New Jersey
Kessler Foundation Research Center Recruiting
West Orange, New Jersey, United States, 07052
Contact: Anthony Lequerica, Ph.D.    973-324-3551    alequerica@kesslerfoundation.net   
Contact: Alexandria Muench    973-324-3540    amuench@kesslerfoundation.net   
Sponsors and Collaborators
Kessler Foundation
Investigators
Principal Investigator: Anthony Lequerica, Ph.D. Kessler Foundation
  More Information

Responsible Party: Anthony Lequerica, Ph.D., Kessler Foundation Research Center
ClinicalTrials.gov Identifier: NCT00775775     History of Changes
Other Study ID Numbers: R45303
First Submitted: October 16, 2008
First Posted: October 20, 2008
Last Update Posted: October 6, 2009
Last Verified: October 2009

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