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

Traumatic Brain Injury Clinical Trial

— OCEANS-TBI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04073225
• Other study ID #: IRB00218229
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: Matthew E Peters, MD
• Phone: 4434783569
• Email: mpeter42[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Brain Injuries
• Brain Injuries, Traumatic
• Dementia Alzheimers
• Military Activity
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 12 weeks, 9 months
Primary	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.	Baseline, 12 weeks, 9 months
Primary	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.	Baseline, 12 weeks, 9 months
Primary	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.	Baseline, 12 weeks, 9 months
Primary	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.	Baseline, 12 weeks, 9 months
Primary	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.	Baseline, 12 weeks
Secondary	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	Baseline, 12 weeks, 9 months
Secondary	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.	Baseline, 12 weeks, 9 months
Secondary	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.	Baseline, 12 weeks, 9 months
Secondary	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."	Baseline, 12 weeks, 9 months
Secondary	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.	Baseline, 12 weeks
Secondary	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.	Baseline, 12 weeks