Clinical trial NCT04073225: Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury
Official title: Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury (OCEANS-TBI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Dementia Alzheimers
Military Activity
Keywords: veteran
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2019-08-29
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Executive functioning as assessed by the Trail Making Test
timeFrame: Baseline, 12 weeks, 9 months
measure: Change in Executive functioning as assessed by the Stroop Test
timeFrame: Baseline, 12 weeks, 9 months
measure: Change in Processing Speed as assessed by the Pattern Comparison Test
timeFrame: Baseline, 12 weeks, 9 months
measure: Change in Verbal Learning as assessed by the Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Baseline, 12 weeks, 9 months
measure: Change in Physical Mobility Outcome as assessed by the Short Physical Performance Battery
timeFrame: Baseline, 12 weeks, 9 months
measure: Change in brain Magnetic Resonance Imaging (MRI) Volumetrics
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in Activity as assessed by the Apple Watch Summary Metric Composite Score
timeFrame: Baseline, 12 weeks, 9 months
measure: Change in Caregiver Burden as assessed by the Zarit Burden Interview
timeFrame: Baseline, 12 weeks, 9 months
measure: Change in Depressive Symptoms as assessed by the Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: Baseline, 12 weeks, 9 months
measure: Change in Neuropsychiatric Symptom Burden as assessed by the Neuropsychiatric Inventory Questionnaire Total Score
timeFrame: Baseline, 12 weeks, 9 months
measure: Change in Brain Diffuse Tensor Imaging (DTI)
timeFrame: Baseline, 12 weeks
measure: Change in Brain Resting State functional MRI (rsfMRI)
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Matthew E Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: