Your session is about to expire
← Back to Search
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks, 9 months
Awards & highlights
OCEANS-TBI Trial 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.Check my eligibility
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.See study design
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.
OCEANS-TBI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
Select...
I can do most daily activities without help or tools like canes.
Select...
I can mostly or completely use my hands and arms on my own.
OCEANS-TBI Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreOCEANS-TBI 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.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,273 Previous Clinical Trials
14,840,326 Total Patients Enrolled
United States Department of DefenseFED
866 Previous Clinical Trials
327,439 Total Patients Enrolled
Matthew E Peters, MDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a mild or moderate head injury more than 3 years ago, according to specific criteria used by the Veterans Affairs / Department of Defense.I am 40 years old or older.I cannot sit or stand and do arm exercises for an hour.Your score on a memory and thinking test is lower than 24.You have had a mild or moderate traumatic brain injury (TBI) at least 3 years ago, as diagnosed by Veteran's Affairs / Department of Defense (VA/DoD) criteria.You have color blindness.I can do most daily activities by myself and have good use of my hands and arms.I can do most daily activities without help or tools like canes.You have a serious mental illness that might make it hard for you to finish the study.I can mostly or completely use my hands and arms on my own.I do not have conditions like epilepsy or Parkinson's that affect movement.I have a condition that severely limits my ability to walk.I can commit 3 hours weekly for 12 weeks to this study.
Research Study Groups:
This trial has the following groups:- Group 1: MindPod Dolphin Arm
- Group 2: Hand Bike Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Traumatic Brain Injury Patient Testimony for trial: Trial Name: NCT04073225 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being admitted into this medical trial?
"Affirmative. The clinical trial, initiated on January 25th 2020 and last updated April 6th 2022 is recruiting 66 patients at a single site according to information hosted on clinicaltrials.gov."
Answered by AI
What objectives does this research endeavor seek to fulfill?
"Baseline and 12-week data will be collected to measure the primary outcome of this study, which is a Change in Executive Functioning as assessed by the Trail Making Test. Secondary endpoints include an alteration in Neuropsychiatric Symptom Burden according to results from the Neuropsychiatric Inventory Questionnaire Total Score; change in Activity via Apple Watch Summary Metric Composite Scores; and variation in Depressive Symptoms through Patient Health Questionnaire - 9 (PHQ-9) responses."
Answered by AI
Are there any vacancies for potential subjects in this investigation?
"Clinicaltrials.gov states that this research project is currently seeking out volunteers, with its initial posting dating back to January 25th 2020 and the last update on April 6th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Johns Hopkins Bayview
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I'm a biomedical engineer who works in medical devices and interested in helping in other folks research. I also had a tough time finding good forms of cognitive therapy after my most recent concussion and am interested in supporting research that could improve that.
PatientReceived 1 prior treatment
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger