Trial Outcomes & Findings for Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming (NCT NCT05103384)
NCT ID: NCT05103384
Last Updated: 2025-11-04
Results Overview
Number of freezing of gait episodes
Recruitment status
COMPLETED
Target enrollment
15 participants
Primary outcome timeframe
Baseline
Results posted on
2025-11-04
Participant Flow
Participant milestones
| Measure |
PD Virtual Reality Cohort
Participants with Parkinson's disease complete cognitive and motor tasks while wearing a virtual reality headset and walking on an omnidirectional treadmill. The virtual reality headset immerses the participant in a virtual home environment designed to elicit freezing of gait episodes. While completing tasks in the virtual home environment, researchers monitor for freezing of gait episodes to investigate neural signatures associated with freezing. Each participant completed the virtual reality modules under two conditions: OFF DBS/OFF PD Meds and OFF DBS/ON PD Meds.
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|---|---|
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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
PD Virtual Reality Cohort
Participants with Parkinson's disease complete cognitive and motor tasks while wearing a virtual reality headset and walking on an omnidirectional treadmill. The virtual reality headset immerses the participant in a virtual home environment designed to elicit freezing of gait episodes. While completing tasks in the virtual home environment, researchers monitor for freezing of gait episodes to investigate neural signatures associated with freezing. Each participant completed the virtual reality modules under two conditions: OFF DBS/OFF PD Meds and OFF DBS/ON PD Meds.
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Overall Study
Too severely affected Off Meds/Off DBS to complete entire protocol
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4
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Baseline Characteristics
Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming
Baseline characteristics by cohort
| Measure |
PD Virtual Reality Cohort
n=11 Participants
Participants with Parkinson's disease complete cognitive and motor tasks while wearing a virtual reality headset and walking on an omnidirectional treadmill. The virtual reality headset immerses the participant in a virtual home environment designed to elicit freezing of gait episodes. While completing tasks in the virtual home environment, researchers monitor for freezing of gait episodes to investigate neural signatures associated with freezing. Each participant completed the virtual reality modules under two conditions: OFF DBS/OFF PD Meds and OFF DBS/ON PD Meds.
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Age, Continuous
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66.8 years
STANDARD_DEVIATION 4.9 • n=15 Participants
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Sex: Female, Male
Female
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5 Participants
n=15 Participants
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Sex: Female, Male
Male
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6 Participants
n=15 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=15 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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10 Participants
n=15 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=15 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=15 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=15 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=15 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=15 Participants
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Race (NIH/OMB)
White
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10 Participants
n=15 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=15 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=15 Participants
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Region of Enrollment
United States
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11 participants
n=15 Participants
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Parkinson's Disease Duration
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10.1 years
STANDARD_DEVIATION 5.1 • n=15 Participants
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Years since DBS Placement
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2.5 years
STANDARD_DEVIATION 3.7 • n=15 Participants
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MDS-UPDRS III, OFF MEDS/OFF DBS
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59.2 score on a scale
STANDARD_DEVIATION 19.7 • n=15 Participants
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PRIMARY outcome
Timeframe: BaselinePopulation: Participants were assessed in the Off DBS/Off Meds condition and Off DBS/On Meds condition for outcome measures. No other conditions were assessed.
Number of freezing of gait episodes
Outcome measures
| Measure |
OFF DBS/OFF PD Meds
n=11 Participants
Session completed with DBS stimulation turned off and participant off their PD meds for 12 hours prior. All analyzed participants completed a session OFF DBS/OFF PD Meds and OFF DBS/ON Meds.
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OFF DBS/ON PD Meds
n=11 Participants
Session completed with DBS stimulation turned off and participant on their PD meds. All analyzed participants completed a session OFF DBS/OFF PD Meds and OFF DBS/ON Meds.
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|---|---|---|
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Freezing of Gait
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2.6 freezing of gait episodes
Standard Deviation 2.6
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1.5 freezing of gait episodes
Standard Deviation 2.1
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SECONDARY outcome
Timeframe: BaselinePopulation: Participants were assessed in the Off DBS/Off Meds condition and Off DBS/On Meds condition for outcome measures. No other conditions were assessed.
Meters/second
Outcome measures
| Measure |
OFF DBS/OFF PD Meds
n=11 Participants
Session completed with DBS stimulation turned off and participant off their PD meds for 12 hours prior. All analyzed participants completed a session OFF DBS/OFF PD Meds and OFF DBS/ON Meds.
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OFF DBS/ON PD Meds
n=11 Participants
Session completed with DBS stimulation turned off and participant on their PD meds. All analyzed participants completed a session OFF DBS/OFF PD Meds and OFF DBS/ON Meds.
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Gait Velocity
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0.27 m/s
Standard Deviation 0.06
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0.29 m/s
Standard Deviation 0.07
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SECONDARY outcome
Timeframe: BaselinePopulation: Participants were assessed in the Off DBS/Off Meds condition and Off DBS/On Meds condition for outcome measures. No other conditions were assessed.
Degrees/second
Outcome measures
| Measure |
OFF DBS/OFF PD Meds
n=11 Participants
Session completed with DBS stimulation turned off and participant off their PD meds for 12 hours prior. All analyzed participants completed a session OFF DBS/OFF PD Meds and OFF DBS/ON Meds.
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OFF DBS/ON PD Meds
n=11 Participants
Session completed with DBS stimulation turned off and participant on their PD meds. All analyzed participants completed a session OFF DBS/OFF PD Meds and OFF DBS/ON Meds.
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Turn Velocity
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21.7 degrees/s
Standard Deviation 6.0
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22.1 degrees/s
Standard Deviation 5.9
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Adverse Events
Off DBS/Off Meds
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Off DBS/On Meds
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Off DBS/Off Meds
n=15 participants at risk
Session completed with DBS stimulation turned off and participant OFF their PD meds for 12 hours prior.
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Off DBS/On Meds
n=15 participants at risk
Session completed with DBS stimulation turned off and participant ON their PD meds.
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Gastrointestinal disorders
Vomiting
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0.00%
0/15 • Through study completion, which was an average of 1 week.
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6.7%
1/15 • Number of events 1 • Through study completion, which was an average of 1 week.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place