N/A
N=23
Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury
Traumatic Brain Injury · Dementia Alzheimers · Military Activity
Bottom Line
View on ClinicalTrials.gov: NCT04073225 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Change in Executive Functioning as Assessed by the Trail Making Test — -9.2; 24.7 change in seconds — p=.323
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MindPod Dolphin (Device); 10 Keys to Healthy Aging (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Executive Functioning as Assessed by the Trail Making Test |
-9.2; 24.7 | .323 |
| PRIMARY Change in Executive Functioning as Assessed by the Stroop Test |
-49.5; 31.8 | .057 |
| PRIMARY Change in Processing Speed Score as Assessed by the Pattern Comparison Test |
2.0; -1.0 | .047 sig |
| PRIMARY Change in Verbal Learning as Assessed by the Rey Auditory Verbal Learning Test (RAVLT) |
1.5; 0.9 | .565 |
| PRIMARY Change in Physical Mobility Outcome as Assessed by the Short Physical Performance Battery |
0.67; -0.60 | 0.147 |
| PRIMARY Change in Brain Magnetic Resonance Imaging (MRI) Hippocampal Volume (mm3) |
-109.7; -10.3 | .605 |
| PRIMARY Change in Brain Magnetic Resonance Imaging (MRI) Amygdala Volume (mm3) |
67.1; -63.7 | .590 |
| SECONDARY Change in Time (Minutes) Spent Outside Home as Assessed by the Apple Watch GPS |
59.99; 35.27 | .743 |
| SECONDARY Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire - 9 (PHQ-9) |
0.10; -1 | 0.731 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04073225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.