Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury (OCEANS-TBI)
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|ClinicalTrials.gov Identifier: NCT04073225|
Recruitment Status : Not yet recruiting
First Posted : August 29, 2019
Last Update Posted : December 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury Dementia Alzheimers||Device: MindPod Dolphin Device: Hand Bike||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury (OCEANS-TBI)|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||June 2022|
Experimental: MindPod Dolphin Arm
Bandit the Dolphin provides an oceanic environment in which the individual's arm movements control a simulated dolphin. The neuromotor effects of this game have been designed to be used in the clinical setting to rehabilitate arm and hand function following stroke.
Device: MindPod Dolphin
The immersive video game being tested in this study is called Bandit the Dolphin, developed by neurologist Dr. John Krakauer, and engineers in the Brain, Learning, Animation, and Movement Lab at Johns Hopkins. Bandit the Dolphin provides an oceanic environment in which the individual's arm movements control a simulated dolphin. The neuromotor effects of this game have been designed to be used in the clinical setting to rehabilitate arm and hand function following stroke. The game has further been modified to a Microsoft Kinect-based system and piloted for play in non-laboratory settings among community-dwelling adults. The game offers a unique combination of skilled arm movements plus varying levels of cognitive challenge. In this way, the individual's arms are challenged the same way the legs would be when walking in a complex, outdoor environment. Importantly, the participant "plays" while standing, thus engaging the whole body in this novel multi-sensorial experience.
Other Name: Bandit the Dolphin
Active Comparator: Hand Bike Arm
Pedal Exerciser, a single-component upper-arm aerobic play. This arm is innovative in its own right, by evaluating the benefits of upper arm aerobic activity on cognitive and physical health given that the vast majority of physical interventions focus on lower-extremity walking and biking exercise.
Device: Hand Bike
The control intervention in this study is a hand bike, a single-component upper-arm aerobic exercise device. This arm is innovative in its own right, by evaluating the benefits of upper arm aerobic activity on cognitive and physical health given that the vast majority of physical interventions focus on lower-extremity walking and biking exercise.
- Change in Executive functioning as assessed by the Trail Making Test [ Time Frame: Baseline, 12 weeks, 9 months ]The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.
- Change in Executive functioning as assessed by the Stroop Test [ Time Frame: Baseline, 12 weeks, 9 months ]The Stroop Test is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.
- Change in Processing Speed as assessed by the Pattern Comparison Test [ Time Frame: Baseline, 12 weeks, 9 months ]This test measures speed of processing by asking participants to discern whether two side-by-side pictures are the same or not.
- Change in Verbal Learning as assessed by the Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: Baseline, 12 weeks, 9 months ]The investigators will assess for change in verbal learning using the RAVLT. The RAVLT is a neuropsychological assessment designed to evaluate verbal memory in patients, 16 years of age and older. The RAVLT can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time. The test is designed as a list-learning paradigm in which the patient hears a list of 15 nouns and is asked to recall as many words from the list as possible.
- Change in Physical Mobility Outcome as assessed by the Short Physical Performance Battery [ Time Frame: Baseline, 12 weeks, 9 months ]The short physical performance battery is a group of measures that combines the results of the gait speed, chair stand and balance tests.
- Change in brain Magnetic Resonance Imaging (MRI) Volumetrics [ Time Frame: Baseline, 12 weeks ]Brain volumetrics will be calculated using a Philips 3 Tesla (T) head-only scanner using established methods. The investigators will obtain various volumetric measures, including: hippocampus, amygdala, mesiotemporal cortex, orbitofrontal cortex, striatum, total gray matter, and total white matter.
- Change in Activity as assessed by the Apple Watch Summary Metric Composite Score [ Time Frame: Baseline, 12 weeks, 9 months ]The investigators will assess physical activity using summary metrics from an Apple Watch. This summary metric is a composition score for: total counts/day (amount); total minutes of activity/day (duration); total bouts of activity/day (duration); levels of activity intensity (sedentary to vigorous); and accumulated time within each activity level
- Change in Caregiver Burden as assessed by the Zarit Burden Interview [ Time Frame: Baseline, 12 weeks, 9 months ]The Zarit Burden Interview (ZBI, 22-item) is one of the most commonly used instruments to assess caregiving burden in clinical and research settings. The ZBI was originally developed to assess burden among caregivers of community-dwelling persons with dementia.
- Change in Depressive Symptoms as assessed by the Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: Baseline, 12 weeks, 9 months ]The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporates Diagnostic and Statistical Manual-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool.
- Change in Neuropsychiatric Symptom Burden as assessed by the Neuropsychiatric Inventory Questionnaire Total Score [ Time Frame: Baseline, 12 weeks, 9 months ]The Neuropsychiatric Inventory - Questionnaire is designed to be a self-administered questionnaire completed by informants about patients for whom informants care for. Each of the 12 domains contains a survey question that reflects cardinal symptoms of that domain. Initial responses to each domain question are "Yes" (present) or "No."
- Change in Brain Diffuse Tensor Imaging (DTI) [ Time Frame: Baseline, 12 weeks ]DTI parameters (FA, MD, RD, AD) will be automatically assessed in 20 predefined regions of interest (ROI) from the Johns Hopkins University DTI-81atlas. Mean values of each DTI parameter for each ROI will be measured.
- Change in Brain Resting State functional MRI (rsfMRI) [ Time Frame: Baseline, 12 weeks ]rsfMRI data will be analyzed using both seed-based (by generating 6mm spheres that will be placed in regions of interest) and group independent component analysis.
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 ClinicalTrials.gov identifier (NCT number): NCT04073225
|Contact: Matthew E Peters, MDemail@example.com|
|Principal Investigator:||Matthew E Peters, MD||Johns Hopkins University|