Software-based Tremor Reduction for Tremor

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NeuroStorm, Inc

Disqualifiers: Dementia, Stroke, Traumatic brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new software designed to reduce hand tremors in people with Parkinson's disease. It uses Virtual Reality (VR) with special TSA algorithms to determine if they can lessen tremor severity. Participants will use either VR with these algorithms or VR alone to compare outcomes. The trial seeks individuals with Parkinson's who can walk unassisted for five minutes and have not fallen in the past six months. As an unphased trial, this study provides a unique opportunity to explore innovative technology that could enhance quality of life.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these tremor stabilization algorithms are safe for Parkinson's patients?

Research has shown that Tremor Stabilization Algorithms (TSA) in virtual reality can significantly reduce tremors in people with Parkinson's disease. In studies, these algorithms reduced tremors in participants' virtual hands by up to 99%, with an average reduction of 76%. This indicates that the algorithms effectively calm tremors when used with VR.

Regarding safety, this treatment involves software, not surgery or medications, which often have side effects. So far, no reports of harm or serious side effects have emerged from using these algorithms in virtual reality. This suggests it could be a safe option for managing tremors in Parkinson's patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach using Tremor Stabilization Algorithms (TSA) in virtual reality environments to reduce tremors. Unlike traditional treatments that rely on medication or surgery, TSA targets tremor reduction through software-based techniques, potentially offering a non-invasive alternative. This method could provide a new way to manage tremors without the side effects associated with drugs or the risks of surgical procedures. By leveraging advanced algorithms within a VR setting, this trial aims to discover if digital interventions can effectively stabilize tremors, opening doors to innovative treatments in neurological care.

What evidence suggests that these Tremor Stabilization Algorithms are effective for reducing tremors in Parkinson's patients?

This trial will compare the use of Tremor Stabilization Algorithms (TSA) in Virtual Reality (VR) environments. Research has shown that TSA can greatly reduce tremors in people with Parkinson's disease. In earlier studies, these algorithms removed up to 99% of tremors from patients' digital hands during activity. Another study found that activating these algorithms significantly reduced involuntary hand tremors for all patients tested. Some personal stories even suggest that these algorithms might help reduce tremors in real life, not just in the VR setting. This information supports the potential effectiveness of TSA algorithms in managing tremors. Participants in this trial will be assigned to either the TSA-ON arm, where the algorithms are active, or the TSA-OFF control arm, where the algorithms are inactive. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can hear and see well enough for daily activities.

Can comply with study requirements

Have the ability to fill online questionnaires

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the experimental group with VR and Tremor Stabilization Algorithms or the control group with VR only. They perform a postural tremor test (PTT) to elicit tremors.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for tremor severity reduction and other secondary outcomes, including self-reported functionality in life.

30 days

Remote self-reports

What Are the Treatments Tested in This Trial?

Interventions

• TSA algorithms

Trial Overview 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.

How Is the Trial Designed?

Group I: TSA-ON Experimental Treatment 1 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 control Active Control 1 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.

Who Is Running the Clinical Trial?

NeuroStorm, Inc

Lead Sponsor

Trials

1

Recruited

300+

stoPD.org

Collaborator

Trials

1

Recruited

300+

Citations

1. medrxiv.org medrxiv.org/content/10.1101/2023.02.05.22283323v1.full-text

Algorithmic Virtual Reality Reduces Parkinsonian Tremor We determined parkinsonian tremors can be abolished in VR with algorithms that removed up to 99% of tremors from PD subjects' digital hands (76% average ...

2. researchgate.net researchgate.net/figure/Parkinsonian-involuntary-hand-tremors-can-be-removed-in-VR-Representative-b-rotational_fig2_339622006

Parkinsonian involuntary hand tremors can be removed in ... Only some patients exhibited IHT (A, C, E, F, H). Of these patients, all had IHT notably reduced in VR when tremor stabilization was turned on (TSA-ON).

3. preprints.org preprints.org/manuscript/202002.0452/v1/download

Virtual Reality tremor reduction in Parkinson's disease With this framework, we observed anecdotal evidence of parkinsonian tremors being reduced in real life when our algorithms abolished digital ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40095435/

Deep Learning-Based Artificial Intelligence Algorithm to ... Supervised DL algorithms can effectively detect tremor syndromes from hand-drawn spirals, offering unbiased, feature-independent classification with higher ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8380769/

A Review on Wearable Technologies for Tremor Suppression Some case reports of SCS treatment for ET (47) and PD (48, 49) have shown its effectiveness in reducing tremor in these patients. These results suggest that ...

6. withpower.com withpower.com/trial/phase-tremor-7-2022-e7844

Software-based Tremor Reduction for Tremor The following trial evaluates the effect of Tremor Stabilization Algorithms on involuntary hand tremors suffered by Parkinson's patients.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9087179/

Assistive Methodologies for Parkinson's Disease Tremor ... This paper provides an overview on controlling the Parkinson's tremor in the hand through assistive methodologies.

8. tremorjournal.org tremorjournal.org/articles/10.5334/tohm.930

Peripheral Devices and Mechanical Strategies to Reduce ... This review discusses non-pharmacological, non-surgical interventions for action tremor, including essential tremor (ET).