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

NCT04073225 | Completed Results DMC FDA Device

• 1 other identifier: IRB00218229
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Dementia Alzheimers; Military Activity

Keywords

veteran

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Change in Time (Minutes) Spent Outside Home as Assessed by the Apple Watch GPS

  Baseline, 12 weeks

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

  Baseline, 12 weeks

Study Arms (2)

MindPod Dolphin Arm

EXPERIMENTAL

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

10 Keys to Healthy Aging

ACTIVE COMPARATOR

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

Interventions

MindPod Dolphin 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.

Also known as: Bandit the Dolphin

MindPod Dolphin Arm

10 Keys to Healthy Aging 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.

10 Keys to Healthy Aging

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Johns Hopkins Bayview

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Dementia; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

A significant limitation of the study was the small sample size. This limited enrollment fell short of the target number needed to achieve sufficient statistical power, which reduced the reliability of the results and limited the ability to detect meaningful intervention effects.

Results Point of Contact

• Title: Michelle Carlson
• Organization: Johns Hopkins University

mcarlso2@jhu.edu

(410) 790-8205

Study Officials

• Matthew E Peters, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Michelle C Carlson, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 29, 2019
• Study Start: January 25, 2020
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: October 7, 2025
• Results First Posted: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)