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ELIMINATE-FOG
Sponsor study identifier
interventional
36
1 country
1
Study Start
November 17, 2022
Actual (reported)Primary Completion
July 28, 2023
Actual (reported)Study Completion
July 28, 2023
Actual (reported)Postural instability, freezing-of-gait (FOG), and falls are among the greatest unmet needs in Parkinson disease (PD). FOG eventually affects more than half of people with PD, and is notoriously difficult to treat pharmacologically or via deep brain stimulation. Visual cues do improve gait freezing, but their efficacy and adoption is limited because they are not practical to use in all real-world situations. There is a need for a cueing technique that is on-demand and discreet - only perceptible to the patient. Fortunately, recent technological advances in augmented-reality (AR) enable such an approach. In this study, state-of-the-art AR glasses will be used to project digital cues that are only visible to the wearer, to determine if they can improve FOG. 36 individuals with PD and FOG will be recruited to perform an obstacle-course gait task under six cue conditions: no cue, conventional cue, constant-on AR, patient-hand-triggered AR (turns on when patient clicks button), patient-eye-triggered AR (turns on when looking down), and examiner-triggered AR. The AR cue is a set of images that appear on the floor at a patient's feet, mimicking floor lines. Gait performance will be captured on video and via body-worn wireless sensors that detect how each limb is moving. The investigators will determine whether individuals are cue-able with conventional visual cues, whether intermittent cues outperform constant-on cues, and whether cues triggered by an examiner outperform cues triggered by patients themselves.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 28, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 31, 2022
Actual (reported)November 8, 2022
Actual (reported)November 17, 2022
Actual (reported)July 28, 2023
Actual (reported)July 28, 2023
Actual (reported)Stride Time Coefficient of Variation
Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.
For each arm, during the single-day research visit only.
Percent Time Freezing
Marker of gait freezing, derived from video recordings of gait performance, and body-worn wireless sensors.
For each arm, during the single-day research visit only.
Step Cadence
For each arm, during the single-day research visit only.
In this single-arm study, all participants will receive all interventions on the same day. They will be wearing an augmented-reality headset that will display a digital obstacle course. Walking performance will be captured with no visual cues, with conventional visual cues, and with augmented-reality visual cues.
There will be no visual cues at all. Will be tested off-medication (after holding morning dopaminergic medications).
Physical lines taped to floor at regular intervals. Will be tested off-medication (after holding morning dopaminergic medications).
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
James Liao, MD PhD
The Cleveland Clinic
36 participants (actual enrollment reported by the registry).
First Submitted
October 31, 2022
First Posted
November 8, 2022
Study Start
Gait Velocity
For each arm, during the single-day research visit only.
Mean Stride Length
For each arm, during the single-day research visit only.
Total Distance Walked
For each arm, during the single-day research visit only.
Freezing Index
For each arm, during the single-day research visit only.
The augmented-reality visual cue will always be turned on. Will be tested off-medication (after holding morning dopaminergic medications).
The augmented-reality visual cue will be turned on, intermittently, each time the patient clicks a handheld button. Will be tested off-medication (after holding morning dopaminergic medications).
The augmented-reality visual cue will be turned on, intermittently, each time the patient looks down at the floor near their feet. Will be tested off-medication (after holding morning dopaminergic medications).
The augmented-reality visual cue will be turned on, intermittently, by an examiner, whenever they feel the patient is having a freezing episode or at risk of having a freezing episode. Will be tested off-medication (after holding morning dopaminergic medications).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
November 17, 2022
Actual (reported)Primary Completion
July 28, 2023
Actual (reported)Study Completion
July 28, 2023
Actual (reported)Last Updated
December 18, 2023
Record last verified: 2023-12
At time of publication, a point of contact individual on the study team will be identified. Third parties will be able to request access to de-identified data used to support the publication findings by application to the Cleveland Clinic IRB. A data use agreement will be put in place between the CCF Cleveland Clinic and this third party for approved use of the data.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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