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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00233090
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : October 5, 2005
Results First Posted : April 15, 2016
Last Update Posted : April 15, 2016
U.S. Department of Education
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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

Condition or disease Intervention/treatment Phase
Fatigue Drug: Modafinil Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post-TBI Fatigue and Its Treatment
Study Start Date : July 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: Modafinil
single dose of 200 mg. a day of modafinil for four weeks
Drug: Modafinil
single dose of 200 mg. a day of modafinil for four weeks

Placebo Comparator: Placebo Drug: Placebo
daily dose of placebo for four weeks.

Primary Outcome Measures :
  1. Fatigue [ Time Frame: comparison pre and post treatment ]
    Self-report of fatigue

Secondary Outcome Measures :
  1. Cognitive Performance [ Time Frame: comparison pre and post treatment ]
    Cognitive performance

  2. Mood [ Time Frame: comparison pre and post treatment ]

  3. Pain [ Time Frame: comparison pre and post treatment ]

  4. Sleep Quality [ Time Frame: comparison pre and post treatment ]
    sleep quality

  5. Health Status [ Time Frame: comparison pre and post treatment ]
    health status

  6. Participation [ Time Frame: comparison pre and post treatment ]

  7. Quality of Life [ Time Frame: comparison pre and post treatment ]
    quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00233090

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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029-6574
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
U.S. Department of Education
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Principal Investigator: Wayne A Gordon, Ph.D. Icahn School of Medicine at Mount Sinai

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Responsible Party: Icahn School of Medicine at Mount Sinai Identifier: NCT00233090     History of Changes
Other Study ID Numbers: GCO #02-0677
First Posted: October 5, 2005    Key Record Dates
Results First Posted: April 15, 2016
Last Update Posted: April 15, 2016
Last Verified: March 2016

Keywords provided by Icahn School of Medicine at Mount Sinai:
brain injury
traumatic brain injury

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action