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

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00233090
First received: October 3, 2005
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Fatigue
Drug: Modafinil
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post-TBI Fatigue and Its Treatment

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Self-report of fatigue [ Time Frame: immediately pre treatment ] [ Designated as safety issue: No ]
    Self-report of fatigue

  • Self-report of fatigue [ Time Frame: immediately post treatment ] [ Designated as safety issue: No ]
    Self-report of fatigue


Secondary Outcome Measures:
  • Cognitive performance [ Time Frame: immediately pre treatment ] [ Designated as safety issue: No ]
    Cognitive performance

  • mood [ Time Frame: immediately pre treatment ] [ Designated as safety issue: No ]
    mood

  • pain [ Time Frame: immediately pre treatment ] [ Designated as safety issue: No ]
    pain

  • sleep quality [ Time Frame: immediately pre treatment ] [ Designated as safety issue: No ]
    sleep quality

  • health status [ Time Frame: immediately pre treatment ] [ Designated as safety issue: No ]
    health status

  • participation [ Time Frame: immediately pre treatment ] [ Designated as safety issue: No ]
    participation

  • quality of life [ Time Frame: immediately pre treatment ] [ Designated as safety issue: No ]
    quality of life

  • Cognitive performance [ Time Frame: immediately post treatment ] [ Designated as safety issue: No ]
    Cognitive performance

  • mood [ Time Frame: immediately post treatment ] [ Designated as safety issue: No ]
    mood

  • pain [ Time Frame: immediately post treatment ] [ Designated as safety issue: No ]
    pain

  • sleep quality [ Time Frame: immediately post treatment ] [ Designated as safety issue: No ]
    sleep quality

  • health status [ Time Frame: immediately post treatment ] [ Designated as safety issue: No ]
    health status

  • participation [ Time Frame: immediately post treatment ] [ Designated as safety issue: No ]
    participation

  • quality of life [ Time Frame: immediately post treatment ] [ Designated as safety issue: No ]
    quality of life


Enrollment: 21
Study Start Date: July 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233090

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

No publications provided

Responsible Party: Wayne Gordon, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00233090     History of Changes
Other Study ID Numbers: 02-0677, H133A020501
Study First Received: October 3, 2005
Last Updated: July 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Fatigue
TBI
brain injury
Modafinil
traumatic brain injury

Additional relevant MeSH terms:
Brain Injuries
Fatigue
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Signs and Symptoms
Trauma, Nervous System
Wounds and Injuries
Armodafinil
Modafinil
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on October 23, 2014