Post-Traumatic Brain Injury (Post-TBI) Fatigue and Its Treatment

Fatigue Clinical Trial

Official title:

Post-TBI Fatigue and Its Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233090
• Other study ID #: 02-0677
• Secondary ID: H133A020501
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2005
• Last updated: July 25, 2011
• Start date: July 2005
• Est. completion date: December 2008

Study information

• Verified date: July 2011
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Randomized clinical trial of modafinil vs. placebo for treatment of fatigue after TBI.

Description:

Purpose: The purpose of this study is to examine the efficacy of the drug modafinil as a treatment for fatigue post TBI.

Background: After TBI, fatigue is one of the most common complaints, as documented in our work and that of many other researchers. People with TBI experience fatigue that seems to them out of proportion to whatever work they are doing or effort they are making. Fatigue after TBI is associated with decreased participation in normal activities in the community and has been linked to depression.

Need for Research: Research on use of drugs to treat post-TBI fatigue is inadequate. While studies of fatigue in people with other chronic conditions suggest that modafinil helps relieve fatigue and has fewer side effects than some other drugs used in treating fatigue, the use of modafinil has not yet been tested in people with TBI.

Current and Future Research Activity: More than 100 men and women volunteers who complain of post-TBI fatigue will be randomly assigned to a 4-week period of taking modafinil or a placebo. At the beginning and end of the study, the severity of their fatigue and associated symptoms (e.g., cognitive function, mood, pain, daytime sleepiness, sleep quality, health status) will be assessed, as well as their participation in activities and perceived quality of life. It is hypothesized that modafinil will reduce the symptoms of fatigue and will increase level of activity and perceived quality of life to a significantly greater extent than will the placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals who sustained a TBI with a documented loss of consciousness or evidence of a TBI on neuroimaging studies and who are at least 12 months post-injury, who complain of fatigue and who have scores of 22 or above on the Barroso Fatigue Scale will be eligible to participate in this study. Subjects must not meet criteria for alcohol or substance abuse using the Structured Clinical Interview for DSM-IV (SCID) for at least six months prior to study enrollment.

Exclusion Criteria:

• Diagnosis of chronic neurological disease (including Lyme disease), narcolepsy, current infectious disease, chronic fatigue syndrome, fibromyalgia, anemia, hypothyroidism not adequately controlled with medication, blood pressure greater 150/100 mm Hg, or clinically significant major systemic disease. In addition, individuals taking medications which are known to cause fatigue will be excluded from participation in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue

Intervention

Drug:
• Modafinil
single dose of 200 mg. a day of modafinil for four weeks
• Placebo
daily dose of placebo for four weeks.

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-report of fatigue	Self-report of fatigue	immediately pre treatment	No
Primary	Self-report of fatigue	Self-report of fatigue	immediately post treatment	No
Secondary	Cognitive performance	Cognitive performance	immediately pre treatment	No
Secondary	mood	mood	immediately pre treatment	No
Secondary	pain	pain	immediately pre treatment	No
Secondary	sleep quality	sleep quality	immediately pre treatment	No
Secondary	health status	health status	immediately pre treatment	No
Secondary	participation	participation	immediately pre treatment	No
Secondary	quality of life	quality of life	immediately pre treatment	No
Secondary	Cognitive performance	Cognitive performance	immediately post treatment	No
Secondary	mood	mood	immediately post treatment	No
Secondary	pain	pain	immediately post treatment	No
Secondary	sleep quality	sleep quality	immediately post treatment	No
Secondary	health status	health status	immediately post treatment	No
Secondary	participation	participation	immediately post treatment	No
Secondary	quality of life	quality of life	immediately post treatment	No