Trial Outcomes & Findings for Wayfinding Intervention in High-Fidelity Long-Term Memory (NCT NCT04253587)
NCT ID: NCT04253587
Last Updated: 2023-02-27
Results Overview
Mnemonic discrimination task testing recognition memory for common objects, as reported in scores on a scale of the Lure Discrimination Index ranging from 0.00 to 1.00 where higher values show better performance.
COMPLETED
NA
50 participants
baseline immediately before and post-assessment immediately after training regimen is completed
2023-02-27
Participant Flow
Participant milestones
| Measure |
LabyrinthVR Trackers
Multi-session cognitive intervention with head-mounted display virtual reality computer game that presents an adaptive spatial wayfinding challenge. Game movement via participant ambulation wearing leg-position trackers.
LabyrinthVR: Head-mounted display virtual reality game designed to induce environmental enrichment in an adaptive, immersive regimen of wayfinding in novel urban and village neighborhoods.
|
Placebo Controls
Multi-session cognitive intervention with handheld tablet or wireless virtual reality headset presentation of commercially available, narrative computer games.
Placebo Games: Commercially-available, narrative computer games marketed as cognitively enriching.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
Baseline T1
|
24
|
21
|
|
Overall Study
Post Training T2
|
21
|
21
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wayfinding Intervention in High-Fidelity Long-Term Memory
Baseline characteristics by cohort
| Measure |
LabyrinthVR Trackers
n=24 Participants
Participants who completed the intervention active training game using head-mounted display virtual reality headset.
|
Placebo Controls
n=21 Participants
Participants who completed the intervention control games using a tablet computer.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Continuous
|
69.1 years
n=5 Participants
|
68.3 years
n=7 Participants
|
68.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline immediately before and post-assessment immediately after training regimen is completedMnemonic discrimination task testing recognition memory for common objects, as reported in scores on a scale of the Lure Discrimination Index ranging from 0.00 to 1.00 where higher values show better performance.
Outcome measures
| Measure |
LabyrinthVR Trackers
n=21 Participants
Participants who completed the intervention active training game using head-mounted display virtual reality headset.
|
Placebo Controls
n=21 Participants
Participants who completed the intervention control games using a tablet computer.
|
|---|---|---|
|
MDT Change in Mnemonic Discrimination
|
0.09 LDI score on a scale
Standard Error 0.03
|
0.01 LDI score on a scale
Standard Error 0.03
|
PRIMARY outcome
Timeframe: baseline immediately before and post-assessment immediately after training regimen is completedEncoding and test of recent autobiographical long-term memory, as reported in scores on a scale of Percentage of Items Recalled ranging from 0.00 to 1.00 where higher values show better performance.
Outcome measures
| Measure |
LabyrinthVR Trackers
n=21 Participants
Participants who completed the intervention active training game using head-mounted display virtual reality headset.
|
Placebo Controls
n=21 Participants
Participants who completed the intervention control games using a tablet computer.
|
|---|---|---|
|
WALK Change in Recall
|
0.03 Items Recalled score on a scale
Standard Error 0.02
|
0.00 Items Recalled score on a scale
Standard Error 0.02
|
PRIMARY outcome
Timeframe: during collection of Outcome 1, baseline immediately before and post-assessment immediately after training regimen is completedPopulation: THESE DATA WERE NOT COLLECTED OR ANALYZED DUE TO FUNDING CONSTRAINTS
Structural MRI T1 data will be analyzed in terms of volumetric-based morphometry and compared between treatment arms and timepoints.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: during collection of Outcome 1, baseline immediately before and post-assessment immediately after training regimen is completedPopulation: THESE DATA WERE NOT COLLECTED OR ANALYZED DUE TO FUNDING CONSTRAINTS
functional MRI data will be analyzed in terms of beta-series correlations between co-active cortical regions of interest and compared between treatment arms and timepoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline immediately before and post-assessment immediately after training regimen is completedPopulation: THESE DATA WERE NOT COLLECTED OR ANALYZED DUE TO FUNDING CONSTRAINTS
A tablet application using a speech-to-text interface to administer neuropsychological tests comparable to CVLT-II verbal memory, verbal fluency, digit span and Trail Making Test-B. Raw scores from the tasks will be transformed to z-scores, relative to population normative values, and a participant's z-scores will be the uniform measures of their performance across RCM tasks. THESE DATA WERE NOT COLLECTED OR ANALYZED DUE TO FUNDING CONSTRAINTS
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline immediately before and post-assessment immediately after training regimen is completedPopulation: THESE DATA WERE NOT COLLECTED OR ANALYZED DUE TO FUNDING CONSTRAINTS
test of speed and accuracy of visual attention and impulsivity
Outcome measures
Outcome data not reported
Adverse Events
LabyrinthVR Trackers
Placebo Controls
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Peter Wais, Principal Investigator
UCSF Dept of Neurology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place