Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury
NCT04073225, Not applicable, Completed, Johns Hopkins University; results first posted 2025-10-07
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury | ClinicalTrials.gov |
| NCT number | NCT04073225 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 23 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Johns Hopkins University | ClinicalTrials.gov |
| Conditions | Traumatic Brain Injury, Dementia Alzheimers, Military Activity | ClinicalTrials.gov |
| Interventions | MindPod Dolphin, 10 Keys to Healthy Aging | ClinicalTrials.gov |
| First posted | 2019-08-29 | ClinicalTrials.gov |
| Last updated | 2025-10-07 | ClinicalTrials.gov |
| Results first posted | 2025-10-07 | ClinicalTrials.gov |
| Limitations and caveats | A significant limitation of the study was the small sample size. This limited enrollment fell short of the target number needed to achieve sufficient statistical power, which reduced the reliability of the results and limited the ability to detect meaningful intervention effects. | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Executive Functioning as Assessed by the Trail Making Test | Baseline, 12 weeks | 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. | ClinicalTrials.gov |
| Primary | Change in Executive Functioning as Assessed by the Stroop Test | Baseline, 12 weeks | 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). | ClinicalTrials.gov |
| Primary | Change in Processing Speed Score as Assessed by the Pattern Comparison Test | Baseline, 12 weeks | 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. | ClinicalTrials.gov |
| Primary | Change in Verbal Learning as Assessed by the Rey Auditory Verbal Learning Test (RAVLT) | Baseline, 12 weeks | 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. | ClinicalTrials.gov |
| Primary | Change in Physical Mobility Outcome as Assessed by the Short Physical Performance Battery | Baseline, 12 weeks | 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. | ClinicalTrials.gov |
| Primary | Change in Brain Magnetic Resonance Imaging (MRI) Hippocampal Volume (mm3) | Baseline, 12 weeks | 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. | ClinicalTrials.gov |
| Primary | Change in Brain Magnetic Resonance Imaging (MRI) Amygdala Volume (mm3) | Baseline, 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in Time (Minutes) Spent Outside Home as Assessed by the Apple Watch GPS | Baseline, 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire - 9 (PHQ-9) | Baseline, 12 weeks | 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. | ClinicalTrials.gov |
Outcomes 9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change in Executive Functioning as Assessed by the Trail Making Test | Baseline, 12 weeks | One participant was excluded due to missing data at both baseline and 12 week visits. | change in seconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Executive Functioning as Assessed by the Stroop Test | Baseline, 12 weeks | One participant was excluded due to missing data at both baseline and 12 week visits. | change in milliseconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Processing Speed Score as Assessed by the Pattern Comparison Test | Baseline, 12 weeks | One participant was excluded due to missing data at both baseline and 12 week visits. | trials | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Verbal Learning as Assessed by the Rey Auditory Verbal Learning Test (RAVLT) | Baseline, 12 weeks | One participant was excluded due to missing data at both baseline and 12 week visits. | words | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Physical Mobility Outcome as Assessed by the Short Physical Performance Battery | Baseline, 12 weeks | 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. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Brain Magnetic Resonance Imaging (MRI) Hippocampal Volume (mm3) | Baseline, 12 weeks | Nine participants who had both baseline and 12 week MRI data were included in this analysis. | mm^3 | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Brain Magnetic Resonance Imaging (MRI) Amygdala Volume (mm3) | Baseline, 12 weeks | Nine participants who had both baseline and 12 week MRI data were included in this analysis. | mm3 | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Time (Minutes) Spent Outside Home as Assessed by the Apple Watch GPS | Baseline, 12 weeks | 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. | minutes | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire - 9 (PHQ-9) | Baseline, 12 weeks | There were 10 intervention and 4 control group participants with available data for PHQ-9 at both baseline and 12-week post-intervention assessments. | score on a scale | MEAN | ClinicalTrials.gov |
Results by group 18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change in Executive Functioning as Assessed by the Trail Making Test | MindPod Dolphin Arm | -9.2 | 95% Confidence Interval -51.5 to 33.1 | change in seconds | ClinicalTrials.gov | |
| Change in Executive Functioning as Assessed by the Trail Making Test | 10 Keys to Healthy Aging | 24.7 | 95% Confidence Interval -27.4 to 76.7 | change in seconds | ClinicalTrials.gov | |
| Change in Executive Functioning as Assessed by the Stroop Test | MindPod Dolphin Arm | -49.5 | 95% Confidence Interval -103.3 to 4.2 | change in milliseconds | ClinicalTrials.gov | |
| Change in Executive Functioning as Assessed by the Stroop Test | 10 Keys to Healthy Aging | 31.8 | 95% Confidence Interval -32.6 to 96.2 | change in milliseconds | ClinicalTrials.gov | |
| Change in Processing Speed Score as Assessed by the Pattern Comparison Test | MindPod Dolphin Arm | 2.0 | 95% Confidence Interval 0.1 to 4.0 | trials | ClinicalTrials.gov | |
| Change in Processing Speed Score as Assessed by the Pattern Comparison Test | 10 Keys to Healthy Aging | -1.0 | 95% Confidence Interval -3.4 to 1.3 | trials | ClinicalTrials.gov | |
| Change in Verbal Learning as Assessed by the Rey Auditory Verbal Learning Test (RAVLT) | MindPod Dolphin Arm | 1.5 | 95% Confidence Interval 0.2 to 2.7 | words | ClinicalTrials.gov | |
| Change in Verbal Learning as Assessed by the Rey Auditory Verbal Learning Test (RAVLT) | 10 Keys to Healthy Aging | 0.9 | 95% Confidence Interval -0.6 to 2.4 | words | ClinicalTrials.gov | |
| Change in Physical Mobility Outcome as Assessed by the Short Physical Performance Battery | MindPod Dolphin Arm | 0.67 | Standard Deviation 1.03 | score on a scale | ClinicalTrials.gov | |
| Change in Physical Mobility Outcome as Assessed by the Short Physical Performance Battery | 10 Keys to Healthy Aging | -0.60 | Standard Deviation 1.83 | score on a scale | ClinicalTrials.gov | |
| Change in Brain Magnetic Resonance Imaging (MRI) Hippocampal Volume (mm3) | MindPod Dolphin Arm | -109.7 | Standard Error 63.1 | mm^3 | ClinicalTrials.gov | |
| Change in Brain Magnetic Resonance Imaging (MRI) Hippocampal Volume (mm3) | 10 Keys to Healthy Aging | -10.3 | Standard Error 192.2 | mm^3 | ClinicalTrials.gov | |
| Change in Brain Magnetic Resonance Imaging (MRI) Amygdala Volume (mm3) | MindPod Dolphin Arm | 67.1 | Standard Error 181.1 | mm3 | ClinicalTrials.gov | |
| Change in Brain Magnetic Resonance Imaging (MRI) Amygdala Volume (mm3) | 10 Keys to Healthy Aging | -63.7 | Standard Error 148.8 | mm3 | ClinicalTrials.gov | |
| Change in Time (Minutes) Spent Outside Home as Assessed by the Apple Watch GPS | MindPod Dolphin Arm | 59.99 | Standard Deviation 172.65 | minutes | ClinicalTrials.gov | |
| Change in Time (Minutes) Spent Outside Home as Assessed by the Apple Watch GPS | 10 Keys to Healthy Aging | 35.27 | Standard Deviation 60.09 | minutes | ClinicalTrials.gov | |
| Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire - 9 (PHQ-9) | MindPod Dolphin Arm | 0.10 | Standard Deviation 4.72 | score on a scale | ClinicalTrials.gov | |
| Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire - 9 (PHQ-9) | 10 Keys to Healthy Aging | -1 | Standard Deviation 6.68 | score on a scale | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | MindPod Dolphin Arm | 14 | ClinicalTrials.gov | |
| Overall Study | STARTED | 10 Keys to Healthy Aging | 9 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | MindPod Dolphin Arm | 10 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | 10 Keys to Healthy Aging | 6 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | MindPod Dolphin Arm | 4 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | 10 Keys to Healthy Aging | 3 | ClinicalTrials.gov |
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | MindPod Dolphin Arm | 0 | 14 | ClinicalTrials.gov |
| Total, all-cause mortality | 10 Keys to Healthy Aging | 0 | 9 | ClinicalTrials.gov |
| Total, other adverse events | MindPod Dolphin Arm | 0 | 14 | ClinicalTrials.gov |
| Total, other adverse events | 10 Keys to Healthy Aging | 0 | 9 | ClinicalTrials.gov |
| Total, serious adverse events | MindPod Dolphin Arm | 0 | 14 | ClinicalTrials.gov |
| Total, serious adverse events | 10 Keys to Healthy Aging | 0 | 9 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MindPod Dolphin Arm vs 10 Keys to Healthy Aging: deaths from any cause | Trial comparisons |
| MindPod Dolphin Arm vs 10 Keys to Healthy Aging: serious adverse events | Trial comparisons |
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Pattern and Letter Comparison | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Task Switching Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)