Trial Outcomes & Findings for Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury (NCT NCT04073225)
NCT ID: NCT04073225
Last Updated: 2025-10-07
Results Overview
The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two timed parts (Part A and B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. Our primary measure was the difference in time (seconds) taking to complete Part B subtracted by Part A, which is an indicator of task-switching.
COMPLETED
NA
23 participants
Baseline, 12 weeks
2025-10-07
Participant Flow
Recruitment sources included Johns Hopkins Alzheimer's Disease Research Center (ADRC), Bayview Community Psychiatry Program (CPP), Johns Hopkins Community Physicians (JHCP), JHCP Clinic Champion: advertises study in JHCP, Clinical Connection, ClinicalTrials.gov, ResearchMatch.org, MyChart, and newsletters/flyers.
Participant milestones
| Measure |
MindPod Dolphin Arm
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.
|
10 Keys to Healthy Aging
The "10 Keys"™ to Healthy Aging Program is designed to teach older adults how to reduce the risk of disease over the aging process by promoting healthy lifestyle changes with the most recent established scientific guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
9
|
|
Overall Study
COMPLETED
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
MindPod Dolphin Arm
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.
|
10 Keys to Healthy Aging
The "10 Keys"™ to Healthy Aging Program is designed to teach older adults how to reduce the risk of disease over the aging process by promoting healthy lifestyle changes with the most recent established scientific guidelines.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
Baseline Characteristics
Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
MindPod Dolphin Arm
n=14 Participants
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.
|
10 Keys to Healthy Aging
n=9 Participants
The "10 Keys"™ to Healthy Aging Program is designed to teach older adults how to reduce the risk of disease over the aging process by promoting healthy lifestyle changes with the most recent established scientific guidelines.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
59.3 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: One participant was excluded due to missing data at both baseline and 12 week visits.
The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two timed parts (Part A and B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. Our primary measure was the difference in time (seconds) taking to complete Part B subtracted by Part A, which is an indicator of task-switching.
Outcome measures
| Measure |
MindPod Dolphin Arm
n=13 Participants
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.
|
10 Keys to Healthy Aging
n=9 Participants
The "10 Keys"™ to Healthy Aging Program is designed to teach older adults how to reduce the risk of disease over the aging process by promoting healthy lifestyle changes with the most recent established scientific guidelines.
|
|---|---|---|
|
Change in Executive Functioning as Assessed by the Trail Making Test
|
-9.2 change in seconds
Interval -51.5 to 33.1
|
24.7 change in seconds
Interval -27.4 to 76.7
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: One participant was excluded due to missing data at both baseline and 12 week visits.
The Stroop Test is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. Our primary measure was the Stroop Effect (i.e., reaction time (milliseconds) for incongruent trials subtracted by reaction time for congruent trials).
Outcome measures
| Measure |
MindPod Dolphin Arm
n=13 Participants
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.
|
10 Keys to Healthy Aging
n=9 Participants
The "10 Keys"™ to Healthy Aging Program is designed to teach older adults how to reduce the risk of disease over the aging process by promoting healthy lifestyle changes with the most recent established scientific guidelines.
|
|---|---|---|
|
Change in Executive Functioning as Assessed by the Stroop Test
|
-49.5 change in milliseconds
Interval -103.3 to 4.2
|
31.8 change in milliseconds
Interval -32.6 to 96.2
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: One participant was excluded due to missing data at both baseline and 12 week visits.
This test measures speed of processing by asking participants to discern whether two side-by-side pictures are the same or not. The processing speed score was the total number of trials completed correctly within the specified time limit.
Outcome measures
| Measure |
MindPod Dolphin Arm
n=13 Participants
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.
|
10 Keys to Healthy Aging
n=9 Participants
The "10 Keys"™ to Healthy Aging Program is designed to teach older adults how to reduce the risk of disease over the aging process by promoting healthy lifestyle changes with the most recent established scientific guidelines.
|
|---|---|---|
|
Change in Processing Speed Score as Assessed by the Pattern Comparison Test
|
2.0 trials
Interval 0.1 to 4.0
|
-1.0 trials
Interval -3.4 to 1.3
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: One participant was excluded due to missing data at both baseline and 12 week visits.
The investigators will assess for change in verbal learning using the RAVLT. The RAVLT is a neuropsychological assessment designed to evaluate verbal memory in patients, 16 years of age and older. The RAVLT can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time. The test is designed as a list-learning paradigm in which the patient hears a list of 15 nouns and is asked to recall as many words from the list as possible. Our primary measure was the number of words correctly recalled after a long delay (20 minutes), an indicator of long-term verbal memory.
Outcome measures
| Measure |
MindPod Dolphin Arm
n=13 Participants
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.
|
10 Keys to Healthy Aging
n=9 Participants
The "10 Keys"™ to Healthy Aging Program is designed to teach older adults how to reduce the risk of disease over the aging process by promoting healthy lifestyle changes with the most recent established scientific guidelines.
|
|---|---|---|
|
Change in Verbal Learning as Assessed by the Rey Auditory Verbal Learning Test (RAVLT)
|
1.5 words
Interval 0.2 to 2.7
|
0.9 words
Interval -0.6 to 2.4
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: There were 10 intervention participants and 6 control group participants that had data collected at both baseline and post-intervention 12-week follow-up assessments.
The Short Physical Performance Battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. We measured the change in SPPB score from baseline to 12-week post-intervention follow-up assessments. Total score of 0 to 12, with a higher score indicating better physical function.
Outcome measures
| Measure |
MindPod Dolphin Arm
n=10 Participants
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.
|
10 Keys to Healthy Aging
n=6 Participants
The "10 Keys"™ to Healthy Aging Program is designed to teach older adults how to reduce the risk of disease over the aging process by promoting healthy lifestyle changes with the most recent established scientific guidelines.
|
|---|---|---|
|
Change in Physical Mobility Outcome as Assessed by the Short Physical Performance Battery
|
0.67 score on a scale
Standard Deviation 1.03
|
-0.60 score on a scale
Standard Deviation 1.83
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Nine participants who had both baseline and 12 week MRI data were included in this analysis.
Brain volumetrics will be calculated using a Philips 3 Tesla (T) head-only scanner using established methods. Hippocampal volumes were automatically segmented using Freesurfer and was summed across both hemispheres to calculate total volume. Change in total hippocampal volume from baseline to 12 weeks was used as the primary measure.
Outcome measures
| Measure |
MindPod Dolphin Arm
n=5 Participants
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.
|
10 Keys to Healthy Aging
n=4 Participants
The "10 Keys"™ to Healthy Aging Program is designed to teach older adults how to reduce the risk of disease over the aging process by promoting healthy lifestyle changes with the most recent established scientific guidelines.
|
|---|---|---|
|
Change in Brain Magnetic Resonance Imaging (MRI) Hippocampal Volume (mm3)
|
-109.7 mm^3
Standard Error 63.1
|
-10.3 mm^3
Standard Error 192.2
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Nine participants who had both baseline and 12 week MRI data were included in this analysis.
Brain volumetrics will be calculated using a Philips 3 Tesla (T) head-only scanner using established methods. Amygdala volumes were automatically segmented using Freesurfer and were summed across both hemispheres to calculate total volume. Change in total amygdala volume from baseline to 12 weeks was used as the primary measure.
Outcome measures
| Measure |
MindPod Dolphin Arm
n=5 Participants
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.
|
10 Keys to Healthy Aging
n=4 Participants
The "10 Keys"™ to Healthy Aging Program is designed to teach older adults how to reduce the risk of disease over the aging process by promoting healthy lifestyle changes with the most recent established scientific guidelines.
|
|---|---|---|
|
Change in Brain Magnetic Resonance Imaging (MRI) Amygdala Volume (mm3)
|
67.1 mm3
Standard Error 181.1
|
-63.7 mm3
Standard Error 148.8
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: There were 10 intervention group participants and 6 control group participants that had data collected for time spent outside of home at both baseline and 12-week post-intervention assessments.
The investigators will assess time spent outside the home from an Apple Watch GPS. Time spent out of home is measured by summing total duration spent in latitude/longitude coordinates that fall outside of a 120 meter radial buffer around the participant's home address.
Outcome measures
| Measure |
MindPod Dolphin Arm
n=10 Participants
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.
|
10 Keys to Healthy Aging
n=6 Participants
The "10 Keys"™ to Healthy Aging Program is designed to teach older adults how to reduce the risk of disease over the aging process by promoting healthy lifestyle changes with the most recent established scientific guidelines.
|
|---|---|---|
|
Change in Time (Minutes) Spent Outside Home as Assessed by the Apple Watch GPS
|
59.99 minutes
Standard Deviation 172.65
|
35.27 minutes
Standard Deviation 60.09
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: There were 10 intervention and 4 control group participants with available data for PHQ-9 at both baseline and 12-week post-intervention assessments.
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporates Diagnostic and Statistical Manual-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe (total score range of 0-27). Higher score worse/more severe symptoms.
Outcome measures
| Measure |
MindPod Dolphin Arm
n=10 Participants
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.
|
10 Keys to Healthy Aging
n=4 Participants
The "10 Keys"™ to Healthy Aging Program is designed to teach older adults how to reduce the risk of disease over the aging process by promoting healthy lifestyle changes with the most recent established scientific guidelines.
|
|---|---|---|
|
Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire - 9 (PHQ-9)
|
0.10 score on a scale
Standard Deviation 4.72
|
-1 score on a scale
Standard Deviation 6.68
|
Adverse Events
MindPod Dolphin Arm
10 Keys to Healthy Aging
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place