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Enrolling By Invitation
NCT05666674
Software-based Modification of Hand Tremors in XR
Conditions: Tremor
Sex: All
Ages: 35 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 300
Sponsor: NeuroStorm, Inc
Location: United States
Summary
The following trial evaluates the effect of Tremor Stabilization Algorithms on involuntary hand tremors suffered by Parkinson's patients.
These algorithms will be implemented in Virtual Reality (VR).
Approximately 300 study subjects are to be randomized to experimental (VR plus algorithms, i.e., intervention) and active comparator (VR only, i.e., control) study arms.
Study subjects will perform a postural tremor test (PTT) to elicit postural parkinsonian tremors.
Our primary outcome is whether the intervention modifies tremor severity.
Eligibility Criteria
Inclusion Criteria:Candidates eligible for our study will be 35 - 85 years, diagnosed with Parkinson's disease, with no falls within 6 months prior to the study, are able to walk for 5 minutes unassisted, have adequate hearing and vision capabilities, can comply with study requirements, have the ability to fill online questionnaires, and provide written informed consent to participate in the study.Exclusion Criteria:Candidates that are ineligible for our study have visual-perceptual deficits that limit capacity to be in VR, have clinical diagnosis of dementia or other severe cognitive impairment as determined by a Mini-Mental State Examination score (MMSE) of less than 24, or have a history of stroke, traumatic brain injury or other neurological disorders
Source: ClinicalTrials.gov (NCT05666674). StuddyBuddy aggregates publicly available trial information.