Software-based Modification of Hand Tremors in XR

Not Applicable

• Conditions: Tremor

• Registration Number: NCT05666674
• Lead Sponsor: NeuroStorm, Inc

Brief 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.

Detailed Description

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. Secondary outcomes include determining whether tremor severity is reduced long-term. These measurements will occur 5 minutes to 30 days post-intervention and will not involve VR. Other secondary outcomes include determining age-of-onset impact on tremor severity, and online self-report surveys for functionality in life in general and in the context of Parkinson's disease. Subjects will perform tremor-recordings on-site. Self-reports will be remote.

Study Timeline

• Study Start: 2022-08-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-18
• Study First Submitted QC: 2022-12-18
• Last Update Submitted: 2022-12-18
• Study First Posted: 2022-12-28
• Last Update Posted: 2022-12-28
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tremor reduction	1 minute	Our primary outcome is the severity of PTT elicited tremors. Tremors will be recorded by VR motion-capture controllers. Wavelet transformation of this data will be applied to determine tremor severity in the two study arms.

Trial Locations

Locations (1)

NeuroStorm; 🇺🇸 New York, New York, United States