NCT04073225Completed
Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury
Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury (OCEANS-TBI)
Source: ClinicalTrials.gov · Last updated 7 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 27 Aug 2019
- Start date
- 25 Jan 2020
- Primary completion date
- 3 Sept 2024
- Lead sponsor
- Johns Hopkins University
- Diseases
- Alzheimer disease
- NCT number
- NCT04073225
What you commit to
- Study type: Interventional
- Participants enrolled: 23
- From 25 Jan 2020 to the primary completion date, 3 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Bayview Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.