Software-based Modification of Hand Tremors in XR

Tremor Clinical Trial

Official title:

Software-based Modification of Hand Tremors in XR

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05666674
• Other study ID #: 0224506734
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: December 2022
• Source: NeuroStorm, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tremor

Intervention

Other:
• TSA algorithms
Our study will be composed of an experimental and an active comparator (i.e., control) arm. Both arms will perform a postural tremor test (PTT) to elicit parkinsonian tremors. The PTT is where subjects stabilize their backs against a wall and position their hands in the air against gravity for two minutes. The experimental arm will receive VR plus activated Tremor Stabilization Algorithms (TSA-ON) while the active comparator arm will receive VR only (TSA-OFF). Thus, subjects in the experimental arm will not see their digital arms tremor while those in the active comparator arm will. Our primary outcome is the severity of PTT elicited tremors. Tremors will be recorded by VR motion-capture controllers.

Locations

Country	Name	City	State
United States	NeuroStorm	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NeuroStorm, Inc	stoPD.org

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tremor reduction	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.	1 minute