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Software-based Modification of Hand Tremors in XR

Primary Purpose

Tremor

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TSA algorithms
Sponsored by
NeuroStorm, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tremor

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NeuroStorm

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TSA-ON

TSF-OFF control

Arm Description

The trial will be composed of two arms: an experimental group with VR with activated Tremor Stabilization Algorithms (TSA-ON). And an active comparator group that is exposed to VR without Tremor Stabilization Algorithms (TSA-OFF control). In both arms, study subjects will be immersed in a stock VR testing environment and will perform a tremor eliciting PTT test.

The trial will be composed of two arms: an experimental group with VR with activated Tremor Stabilization Algorithms (TSA-ON). And an active comparator group that is exposed to VR without Tremor Stabilization Algorithms (TSA-OFF control). In both arms, study subjects will be immersed in a stock VR testing environment and will perform a tremor eliciting PTT test.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2022
Last Updated
December 18, 2022
Sponsor
NeuroStorm, Inc
Collaborators
stoPD.org
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1. Study Identification

Unique Protocol Identification Number
NCT05666674
Brief Title
Software-based Modification of Hand Tremors in XR
Official Title
Software-based Modification of Hand Tremors in XR
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NeuroStorm, Inc
Collaborators
stoPD.org

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tremor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The trial will be composed of two arms: an experimental group with VR with activated Tremor Stabilization Algorithms (TSA-ON). And an active comparator group that is exposed to VR without Tremor Stabilization Algorithms (TSA-OFF control). In both arms, study subjects will be immersed in a stock VR testing environment and will perform a tremor eliciting PTT test.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TSA-ON
Arm Type
Experimental
Arm Description
The trial will be composed of two arms: an experimental group with VR with activated Tremor Stabilization Algorithms (TSA-ON). And an active comparator group that is exposed to VR without Tremor Stabilization Algorithms (TSA-OFF control). In both arms, study subjects will be immersed in a stock VR testing environment and will perform a tremor eliciting PTT test.
Arm Title
TSF-OFF control
Arm Type
Active Comparator
Arm Description
The trial will be composed of two arms: an experimental group with VR with activated Tremor Stabilization Algorithms (TSA-ON). And an active comparator group that is exposed to VR without Tremor Stabilization Algorithms (TSA-OFF control). In both arms, study subjects will be immersed in a stock VR testing environment and will perform a tremor eliciting PTT test.
Intervention Type
Other
Intervention Name(s)
TSA algorithms
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tremor reduction
Description
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.
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
NeuroStorm
City
New York
State/Province
New York
ZIP/Postal Code
11233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Software-based Modification of Hand Tremors in XR

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