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

Primary Purpose

Traumatic Brain Injury, Dementia Alzheimers, Military Activity

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MindPod Dolphin

Hand Bike

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring veteran

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Johns Hopkins BayviewRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MindPod Dolphin Arm

Hand Bike Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 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

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

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)

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

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

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

Change in Activity as assessed by the Apple Watch Summary Metric Composite Score

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

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)

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

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)

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)

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.

Full Information

NCT ID

NCT04073225

First Posted

August 27, 2019

Last Updated

December 9, 2022

Sponsor

Johns Hopkins University

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT04073225

Brief Title

Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury

Acronym

OCEANS-TBI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 25, 2020 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury, Dementia Alzheimers, Military Activity

Keywords

veteran

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MindPod Dolphin Arm

Arm Type

Experimental

Arm Description

Arm Title

Hand Bike Arm

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

MindPod Dolphin

Other Intervention Name(s)

Bandit the Dolphin

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Hand Bike

Intervention Description

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 Measure Information:

Title

Change in Executive functioning as assessed by the Trail Making Test

Description

Time Frame

Baseline, 12 weeks, 9 months

Title

Change in Executive functioning as assessed by the Stroop Test

Description

Time Frame

Baseline, 12 weeks, 9 months

Title

Change in Processing Speed as assessed by the Pattern Comparison Test

Description

This test measures speed of processing by asking participants to discern whether two side-by-side pictures are the same or not.

Time Frame

Baseline, 12 weeks, 9 months

Title

Change in Verbal Learning as assessed by the Rey Auditory Verbal Learning Test (RAVLT)

Description

Time Frame

Baseline, 12 weeks, 9 months

Title

Change in Physical Mobility Outcome as assessed by the Short Physical Performance Battery

Description

The short physical performance battery is a group of measures that combines the results of the gait speed, chair stand and balance tests.

Time Frame

Baseline, 12 weeks, 9 months

Title

Change in brain Magnetic Resonance Imaging (MRI) Volumetrics

Description

Time Frame

Baseline, 12 weeks

Secondary Outcome Measure Information:

Title

Change in Activity as assessed by the Apple Watch Summary Metric Composite Score

Description

Time Frame

Baseline, 12 weeks, 9 months

Title

Change in Caregiver Burden as assessed by the Zarit Burden Interview

Description

Time Frame

Baseline, 12 weeks, 9 months

Title

Change in Depressive Symptoms as assessed by the Patient Health Questionnaire - 9 (PHQ-9)

Description

Time Frame

Baseline, 12 weeks, 9 months

Title

Change in Neuropsychiatric Symptom Burden as assessed by the Neuropsychiatric Inventory Questionnaire Total Score

Description

Time Frame

Baseline, 12 weeks, 9 months

Title

Change in Brain Diffuse Tensor Imaging (DTI)

Description

Time Frame

Baseline, 12 weeks

Title

Change in Brain Resting State functional MRI (rsfMRI)

Description

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.

Time Frame

Baseline, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Matthew E Peters, MD

Phone

4434783569

mpeter42@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew E Peters, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Bayview

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthew E Peters, MD

Phone

443-478-3569

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury

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