Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury (OCEANS-TBI)

Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury (OCEANS-TBI)

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury; Dementia Alzheimers; Military Activity
• Intervention / Treatment: Device: MindPod Dolphin; Behavioral: 10 Keys to Healthy Aging

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Bandit the Dolphin
Active Comparator: 10 Keys to Healthy Aging; The "10 Keys"™ to Healthy Aging Program is designed to teach older adults how to reduce the risk of disease over the aging process by promoting healthy lifestyle changes with the most recent established scientific guidelines.	Behavioral: 10 Keys to Healthy Aging; The "10 Keys"™ to Healthy Aging Program in an evidence-based program that originated from the University of Pittsburgh Center for Aging and Population Health. This educates and empowers older adults to reach personal goals and help others to so in the community as well. It is designed to teach older adults how to reduce the risk of disease over the aging process by promoting healthy lifestyle changes with the most recent established scientific guidelines. The 10 Keys program also aims to empower individuals to be health ambassadors in the individual's own families and communities, teaching individuals to 'Share the Wealth on Health'. Participants will work towards personal health goal(s) adapted to the participant's lifestyle and abilities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Executive Functioning as Assessed by the Trail Making Test	The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two timed parts (Part A and B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. Our primary measure was the difference in time (seconds) taking to complete Part B subtracted by Part A, which is an indicator of task-switching.	Baseline, 12 weeks
Change in Executive Functioning as Assessed by the Stroop Test	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. Our primary measure was the Stroop Effect (i.e., reaction time (milliseconds) for incongruent trials subtracted by reaction time for congruent trials).	Baseline, 12 weeks
Change in Processing Speed Score as Assessed by the Pattern Comparison Test	This test measures speed of processing by asking participants to discern whether two side-by-side pictures are the same or not. The processing speed score was the total number of trials completed correctly within the specified time limit.	Baseline, 12 weeks
Change in Verbal Learning as Assessed by the Rey Auditory Verbal Learning Test (RAVLT)	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. Our primary measure was the number of words correctly recalled after a long delay (20 minutes), an indicator of long-term verbal memory.	Baseline, 12 weeks
Change in Physical Mobility Outcome as Assessed by the Short Physical Performance Battery	The Short Physical Performance Battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. We measured the change in SPPB score from baseline to 12-week post-intervention follow-up assessments. Total score of 0 to 12, with a higher score indicating better physical function.	Baseline, 12 weeks
Change in Brain Magnetic Resonance Imaging (MRI) Hippocampal Volume (mm3)	Brain volumetrics will be calculated using a Philips 3 Tesla (T) head-only scanner using established methods. Hippocampal volumes were automatically segmented using Freesurfer and was summed across both hemispheres to calculate total volume. Change in total hippocampal volume from baseline to 12 weeks was used as the primary measure.	Baseline, 12 weeks
Change in Brain Magnetic Resonance Imaging (MRI) Amygdala Volume (mm3)	Brain volumetrics will be calculated using a Philips 3 Tesla (T) head-only scanner using established methods. Amygdala volumes were automatically segmented using Freesurfer and were summed across both hemispheres to calculate total volume. Change in total amygdala volume from baseline to 12 weeks was used as the primary measure.	Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Time (Minutes) Spent Outside Home as Assessed by the Apple Watch GPS	The investigators will assess time spent outside the home from an Apple Watch GPS. Time spent out of home is measured by summing total duration spent in latitude/longitude coordinates that fall outside of a 120 meter radial buffer around the participant's home address.	Baseline, 12 weeks
Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire - 9 (PHQ-9)	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. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe (total score range of 0-27). Higher score worse/more severe symptoms.	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Matthew E Peters, MD, Johns Hopkins University; Principal Investigator: Michelle C Carlson, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2020
• Primary Completion (Actual): September 3, 2024
• Study Completion (Actual): September 3, 2024

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 29, 2019

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: veteran
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Wounds and Injuries; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Alzheimer Disease
• Other Study ID Numbers: IRB00218229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes