A Phase 1/2 interventional study of Elliptical exercise in Adult, Traumatic Brain Injury and fMRI, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by National Institutes of Health Clinical Center (CC) · Phase 1/2, Interventional, and Treatment
Background:
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:
Objectives: 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.
1,775 studies on the registry are indexed under Brain Injuries, Traumatic; 448 are open to participants now.
This study's enrollment of 34 is below the median of 56 across 1,133 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
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Inclusion criteria for all subjects (healthy volunteers and those with TBI) include:
-ages 18 - 44, inclusive
Additional inclusion criteria for those with TBI include:diagnosis of traumatic brain injury
EXCLUSION CRITERIA:
have any of the following contraindications to having an MRI scan:
Additional exclusion criteria for those with TBI include:
-Planning to make a change in medication or therapy during the enrollment period with the goal of improving mood, cognitive function or motor function.
Home base exercise
Other: Elliptical exercise
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.
1. HiMAT is a composite measure of high functioning mobility skills. 2. Limits of Stability instrumented balance test wih a focus on response speed3. Hamilton Depression (HAM-D) inventory to evaluate changesin emotional health
Primary outcomes are Hi-MAT score, reaction time during balance testing and the Hamilton Rating Scale for Depression (Ham-D).
Time frame: 0, 2, and 4 months
1. movement speed and reaction time during a range of motor tasks2. Other aspects of balance tests (e.g. directionality)3. scores on neuropsychological tests4. analysis of brain pathway volume and connectivity
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.
Time frame: 0, 2, and 4 months
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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National Institutes of Health Clinical Center (CC)