Recruiting

Observational Study

Sponsor:

Kessler Foundation

Code:

NCT00775775

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Traumatic Brain Injury

Study ID

NCT00775775

Start date

May, 2003

Status verified date

Oct, 2009

Completion date

Dec, 2009

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

TBI

Patients with moderate to severe TBI

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Anthony Lequerica, Ph.D.

973-324-3551alequerica@kesslerfoundation.net

Alexandria Muench

973-324-3540amuench@kesslerfoundation.net

Locations

Kessler Foundation Research Center

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Anthony Lequerica, Ph.D.

973-324-3551alequerica@kesslerfoundation.net

Alexandria Muench

973-324-3540amuench@kesslerfoundation.net

More Information

Sponsor

Kessler Foundation

Last update posted

Oct 6, 2009

Last verified

Oct, 2009

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2009-10-06.