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

NCT ID: NCT04073225

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-25
• Study Completion Date: 2024-09-03

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.

Conditions

Traumatic Brain Injury; Dementia Alzheimers; Military Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

MindPod Dolphin

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

10 Keys to Healthy Aging

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Bandit the Dolphin

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew E Peters, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Michelle C Carlson, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00218229

Identifier Type: -

Identifier Source: org_study_id