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

Post-TBI Fatigue and Its Treatment

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00233090

Enrollment

Registered

2005-10-05

Start date

2005-07-31

Completion date

2008-12-31

Last updated

2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue

Keywords

Fatigue, TBI, brain injury, Modafinil, traumatic brain injury

Brief summary

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

Detailed 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.

Interventions

DRUGModafinil

single dose of 200 mg. a day of modafinil for four weeks

DRUGPlacebo

daily dose of placebo for four weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Fatigue	comparison pre and post treatment	Self-report of fatigue

Secondary

Measure	Time frame	Description
Mood	comparison pre and post treatment	mood
Pain	comparison pre and post treatment	pain
Sleep Quality	comparison pre and post treatment	sleep quality
Cognitive Performance	comparison pre and post treatment	Cognitive performance
Participation	comparison pre and post treatment	participation
Quality of Life	comparison pre and post treatment	quality of life
Health Status	comparison pre and post treatment	health status

Countries

United States

Participant flow

Participants by arm

Arm	Count
Modafinil single dose of 200 mg. a day of modafinil for four weeks	12
Placebo daily dose of placebo for four weeks	9
Total	21

Baseline characteristics

Characteristic	Modafinil	Placebo	Total
Age, Continuous	52 years STANDARD_DEVIATION 12	54 years STANDARD_DEVIATION 13	53 years STANDARD_DEVIATION 12
Region of Enrollment United States	12 participants	9 participants	21 participants
Sex: Female, Male Female	8 Participants	3 Participants	11 Participants
Sex: Female, Male Male	4 Participants	6 Participants	10 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 12	0 / 9
serious Total, serious adverse events	0 / 12	0 / 9