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Behavioural Intervention

Immersive Computer Game + Exercise for Traumatic Brain Injury (OCEANS-TBI Trial)

N/A

Recruiting

Led By Matthew E Peters, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

40 years of age and older

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)

Must not have

Inability to sit in a chair or stand and perform upper limb exercises for one hour at a time

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 weeks, 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether an immersive computer game can help improve cognition for adults with a history of TBI.

Who is the study for?

This trial is for English-speaking adults over 40 with a history of mild to moderate traumatic brain injury (TBI) from at least 3 years ago. Participants should be fairly independent in daily activities, not using walking aids, and able to commit to around 20-26 hours over 12 weeks. They must score above a certain level on an arm and hand activity test and cannot have severe cognitive impairments or conditions affecting motor function.

What is being tested?

The study tests the effectiveness of MindPod Dolphin, an immersive computer game combining physical and cognitive exercises, against the use of a Hand Bike. The goal is to see if these complex motor activities can improve neurocognitive functions in those with TBI histories that may lead to Alzheimer's disease or related dementias.

What are the potential side effects?

Since this trial involves non-invasive interventions like computer games and exercise equipment, side effects are minimal but could include muscle soreness or fatigue due to physical activity involved in the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 years old or older.

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I can do most daily activities without help or tools like canes.

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I can mostly or completely use my hands and arms on my own.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot sit or stand and do arm exercises for an hour.

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I do not have conditions like epilepsy or Parkinson's that affect movement.

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I have a condition that severely limits my ability to walk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 weeks, 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 weeks, 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks, 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Executive functioning as assessed by the Stroop Test

Change in Executive functioning as assessed by the Trail Making Test

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

+3 more

Secondary study objectives

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

Change in Brain Diffuse Tensor Imaging (DTI)

Change in Brain Resting State functional MRI (rsfMRI)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MindPod Dolphin ArmExperimental Treatment1 Intervention

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 II: Hand Bike ArmActive Control1 Intervention

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.

0 / 6Eligibility criteria met