Fatigue, Sleep Disorders and Endocrine Abnormalities in TBI Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Kessler Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kessler Foundation
ClinicalTrials.gov Identifier:
NCT00775775
First received: October 16, 2008
Last updated: October 2, 2009
Last verified: October 2009
  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 ] [ 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 ]

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
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, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Anthony Lequerica, Ph.D., Kessler Foundation Research Center
ClinicalTrials.gov Identifier: NCT00775775     History of Changes
Other Study ID Numbers: R45303
Study First Received: October 16, 2008
Last Updated: October 2, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014