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
Recruitment status was Recruiting
Sponsor:
Kessler Foundation
Information provided by:
Kessler Foundation
ClinicalTrials.gov Identifier:
NCT00775775
First received: October 16, 2008
Last updated: October 2, 2009
Last verified: October 2009
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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
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:
|
Congenital Abnormalities Sleep Disorders Parasomnias Brain Injuries Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
Mental Disorders Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013