Effects of Rapid-Resisted Exercise and Bright Light Therapy on Ambulatory Adults With Traumatic Brain Injury
Condition: Adult; Traumatic Brain Injury; fMRI
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Background:

        -  Traumatic brain injury may have a range of effects, from severe and permanent disability
           to more subtle functional and cognitive deficits that often go undetected during initial
           treatment. To improve treatments and therapies and to provide a uniform quality of care,
           more research is needed into different treatments for traumatic brain injury.

        -  Exercise has been shown to improve movement and balance in people with strokes, cerebral
           palsy, and other conditions that affect the brain, and can improve symptoms of memory
           problems or depression. Bright light therapy has also been shown to improve mood in
           people with depression. Researchers are interested in studying problems with movement,
           balance, thinking, and mood in people with traumatic brain injury. By comparing the
           effects of exercise and bright light exposure on brain function, new treatments may be
           developed for acute traumatic brain injury.

      Objectives:

      - To compare the effects of exercise and bright light therapy on the brain function of
      individuals with traumatic brain injury.

      Eligibility:

      - Individuals between 18 and 44 years of age who either have been diagnosed with traumatic
      brain injury or are healthy volunteers.

      Design:

        -  Individuals with traumatic brain injury will have four outpatient evaluation visits at
           the clinical center, a 3-month home exercise program, and a 3-month bright light
           exposure program at home. Healthy volunteers will have one evaluation visit at the
           clinical center.

        -  At the first study visit, all participants will have a full physical examination and
           medical history. Individuals with traumatic brain injury will also have an eye exam to
           determine if it is safe for them to receive light therapy.

        -  All participants will have the following initial tests:

        -  Tests of walking and movement, including monitoring by a physical therapist; tests to
           record joint movement and evaluate muscle function; tests that combine movement,
           thinking, and speaking; and balance and reaction time tests.

        -  Magnetic resonance imaging scans

        -  Tests of thinking and mood, including questionnaires, computerized tests, and simple
           action tests.

        -  Participants with traumatic brain injury will have separate 3-month sessions of exercise
           and bright light therapy, with additional evaluation visits between each 3-month session
           and at the end of the study. Between the 3-month sessions, participants will have 1
           month with no intervention.

        -  Exercise sessions will involve regular workouts on an elliptical machine for 30 minutes
           for 5 days a week, and bright light therapy sessions will involve sitting in front of a
           light box for 30 minutes for 5 days a week. Participants will keep a journal to monitor
           the effects of the therapy.
    

Detailed description: 
      We will: 1) compare performance of healthy volunteers and ambulatory adults with traumatic
      brain injury (TBI) on a range of motor, neurobehavioral and brain imaging outcomes; and 2)
      evaluate effects of rapid, reciprocal arm and leg exercise with an elliptical trainer on
      high-level motor coordination and balance, and neurobehavioral and cognitive functioning in
      persons with TBI. Brain connectivity and changes in connectivity in response to intervention
      will be quantified. We hypothesize even highly functional adults with TBI will have poorer
      scores on all measures than controls; exercise will lead to significant improvements in motor
      performance and balance,and neurobehavioral and cognitive functioncompared to an equivalent
      length of time during which they were not participating in training . We further hypothesize
      that improvements in cortical connectivity and representation will relate directly to
      functional ones.

      Study Population: 80 adults (50 with TBI) will be recruited so that 20 with TBI and 20
      healthy volunteers complete the study. Only the TBI group will receive intervention.

      Design: Healthy controls with have a single assessment that includes motor,
      neuropsychological and brain imaging tests. Participants with TBI will have 3 visits with the
      same motor, neuropsychological and brain imaging tests as the healthy controls. They will
      perform 2 months of fast elliptical training. . Assessments will occur at 0, 2, and 4 months.
      The exercise device will be an elliptical trainer that exercises the legs and arms with the
      emphasis on maintaining a fast speed. Mild resistance will be provided initially and
      progressively increased once speed is optimized. . The training will be performed in the home
      5 days per week for 30 minutes.

      Outcome Measures: Performance on complex motor and balance tasks will be assessed with 3D
      motion capture & EMG, the Smart Balance Measurement System and the High Level Mobility
      Assessment Tool (Hi-MAT). Primary outcomes are Hi-MAT score, reaction time during balance
      testing and the Hamilton Rating Scale for Depression (Ham-D). Secondary outcomes will include
      measures of motor speed and reaction time, dual task performance, memory, anxiety, sleep
      quality, and responses to stress. Cortical connectivity will be quantified using resting
      state functional connectivity magnetic resonance imaging (MRI) and Diffusion Tensor Imaging
      (DTI), which evaluates white matter tracts. Cortical activation patterns during imagined
      walking will be quantified with fMRI.
    

Intervention name(s): Elliptical exercise
Intervention type(s): Other
Intervention description(s): Each participant with TBI will participate in an exercise intervention which will be done in the home. The exercise device in this protocol will be an elliptical trainer that requires coordinated reciprocal movements of both the legs and the arms. Primary emphasis will be placed on maintaining a near maximal speed of movement and to progressively increase this over time. Mild resistance to the leg motion will be provided initially and will be progressively increased once speed and coordination are optimized. The device will be loaned to them to use in the home, and will be delivered to the home fully assembled. Participants will be monitored by phone the first week and thereafter every two weeks and progressed as indicated. The exercise program will be performed 5 days a week for 30 minutes per session, for a total duration of 12 weeks. All will record the length, speed and resistance of each session on a paper-based log sheet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Motor Training; Post-Traumatic Stress Disorder (PTSD); Balance