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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
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Patients with a history of traumatic brain injury (TBI) are at elevated risk for Alzheimer's disease and related dementias (ADRD). Improvements in TBI treatment may mitigate this risk. Complex motor activities, which combine physical and cognitive demands, have been shown to have well established neurocognitive benefits. This study seeks to address the need for novel TBI interventions optimized for adults with history of TBI by determining the effectiveness of an immersive computer game designed to integrating complex cognitive-motor interventions.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Dementia Alzheimers Device: MindPod Dolphin Device: Hand Bike Not Applicable

Detailed Description:
Patients with a history of traumatic brain injury (TBI) are at elevated risk for Alzheimer's disease and related dementias (ADRD). Improvements in TBI treatment may mitigate this risk. The treatment of TBI, especially for those with chronic neuropsychiatric sequelae, is moving toward multi-modal approaches that include non-pharmacological interventions such as exercise and cognitive enrichment. Complex motor activities, which combine physical and cognitive demands, have been shown to have well established neurocognitive benefits. However, there are a lack of cognitive enhancing interventions that utilize these complex motor activities. Many adults with history of TBI face significant barriers to engaging in physical activity which limit the adults' ability to participate in many neurocognitive interventions. This study seeks to address the need for novel TBI interventions optimized for adults with history of TBI by determining the effectiveness of an immersive computer game designed to integrating complex cognitive-motor interventions. During this proposed 12-month study involving patients with history of TBI (n=66) the investigators will examine cognition, independent function, mood and ADRD related brain biomarkers after 12 weeks of a randomized intervention, as well as 9 months post-intervention to assess for durability of any benefits. The investigators hypothesize that complex motor activities will improve cognitive health in adults with a history of TBI and that promising results would have implications for early intervention for those at risk for Mild Cognitive Impairment and ADRD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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."

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English speaking
  • 40 years of age and older
  • History of at least one remote TBI (>3 years ago) of mild and moderate severity as diagnosed by Veteran's Affairs / Department of Defense (VA/DoD) criteria.
  • Ability to perform most independent activities of daily living without physical assistance (e.g., no canes or walkers because person needs both hands to participate); Chedoke Arm and Hand Activity Inventory - mean score >5, indicating modified or complete independence in hand and arm functioning.
  • Ability to dedicate 3 hours per week for about 12 weeks—approximately 20 to 26 hours of total time—to the intervention study.
  • Ability to give informed consent and understand the tasks involved

Exclusion Criteria:

  • Presence of cognitive impairment based on a Mini-Mental State Exam (MMSE) score ≤ 24.
  • Presence of diseases associated with gross motor abnormalities that restrict ambulation (e.g., stroke with paresis, multiple sclerosis, amyotrophic lateral sclerosis, cerebellar or spinal cord disorders, peripheral nerve disorders, severe rheumatic or osteoarthritic disorders, limb amputation)
  • Untreated major mental illness that may preclude successful completion of the study (e.g., major depressive disorder, anxiety disorders, etc.)
  • History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g., epilepsy, severe arthritis, severe neuropathy, Parkinson's disease).
  • Current diagnosis of color blindness.
  • Social or personal circumstances that interfere with ability to complete 12-14 weeks of training sessions and follow-up evaluation.
  • Inability to sit in a chair or stand and perform upper limb exercises for one hour at a time.

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 ClinicalTrials.gov identifier (NCT number): NCT04073225


Contacts
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Contact: Matthew E Peters, MD 4434783569 mpeter42@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
United States Department of Defense
Investigators
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Principal Investigator: Matthew E Peters, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04073225     History of Changes
Other Study ID Numbers: IRB00218229
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Alzheimer Disease
Dementia
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases