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Behavioural Intervention
Software-based Tremor Reduction for Tremor
N/A
Waitlist Available
Research Sponsored by NeuroStorm, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have adequate hearing and vision capabilities
Candidates eligible for our study will be 35 - 85 years, diagnosed with Parkinson's disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 minute
Awards & highlights
Study Summary
This trial tests the effect of algorithms used in VR to reduce the severity of tremors in Parkinson's patients. 300 people will participate and compare tremor severity with/without the intervention.
Who is the study for?
This trial is for people aged 35-85 with Parkinson's disease who can see and hear well, walk unassisted for 5 minutes, fill out online forms, haven't fallen in the last 6 months, and can follow study rules. Those with severe cognitive issues, a history of stroke or brain injury, or trouble with VR due to visual problems cannot join.Check my eligibility
What is being tested?
The trial tests Tremor Stabilization Algorithms (TSA) within Virtual Reality (VR) to reduce hand tremors in Parkinson's patients. Participants are split into two groups: one uses VR plus TSA (intervention), while the other uses only VR (control). Their tremor severity after using these systems is measured as the main outcome.See study design
What are the potential side effects?
Since this intervention involves software algorithms within a VR environment rather than medication, typical drug side effects aren't expected. However, participants may experience discomfort from wearing VR equipment like dizziness or nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can hear and see well enough for daily activities.
Select...
I am between 35 and 85 years old and have been diagnosed with Parkinson's disease.
Select...
I can walk for 5 minutes without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 minute
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 minute
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tremor reduction
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TSA-ONExperimental Treatment1 Intervention
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.
Group II: TSF-OFF controlActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
NeuroStorm, IncLead Sponsor
stoPD.orgUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stroke, brain injury, or other neurological disorders.I have been diagnosed with dementia or severe cognitive impairment.I do not have vision problems that would prevent me from using VR.I can hear and see well enough for daily activities.I am between 35 and 85 years old and have been diagnosed with Parkinson's disease.You haven't had any falls in the 6 months before the study.I can walk for 5 minutes without help.
Research Study Groups:
This trial has the following groups:- Group 1: TSA-ON
- Group 2: TSF-OFF control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the trial presently accepting new participants?
"Clinicaltrials.gov reveals that this medical experiment, which was first posted on August 1st 2022 and last updated on December 18th of the same year, is not currently looking to recruit new patients. However, numerous other trials are presently enrolling participants; 47 available studies can be found right now."
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