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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the TSA algorithms treatment for tremor reduction?

Research on a wearable orthosis with an algorithm for tremor suppression showed a significant reduction in tremor energy, with a decrease from 55.49 to 15.66 in active mode, indicating that similar software-based approaches could be effective for tremor reduction. ^{1 2 3 4 5}

Is the software-based tremor reduction treatment safe for humans?

Research on wearable tremor suppression devices (WTSDs) shows they can be safe for use, even in unexpected situations, with improved safety features like fault-tolerant control systems. These devices have been tested and found to remain functional and safe, making them a promising option for managing tremors. ^{1 2 3 6 7}

How does the TSA algorithm treatment for tremor differ from other treatments?

The TSA algorithm treatment for tremor is unique because it uses software to analyze and reduce tremors by detecting specific tremor patterns through advanced algorithms, unlike traditional treatments that may rely on medication or physical therapy. This approach allows for personalized and precise tremor management by continuously monitoring and adjusting to the patient's tremor characteristics. ^{8 9 10 11 12}

Eligibility Criteria

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

I am between 35 and 85 years old and have been diagnosed with Parkinson's disease.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment options for early Parkinson's disease. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Therapeutic advances in tremor. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A noninvasive handheld assistive device to accommodate essential tremor: a pilot study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of a wearable orthosis and an associated algorithm for tremor suppression. [2007]

5. England pubmed.ncbi.nlm.nih.gov

Computational study and validation of a novel passive hand tremor attenuator. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The treatment of tremor. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Preliminary Assessment of the Safety of a Fault-Tolerant Control-based Wearable Tremor Suppression Glove. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Power Spectral Density-Based Method to Detect Tremor and Tremor Intermittency in Movement Disorders. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Validation for tremor quantification of an electromagnetic tracking device. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Adaptive Fourier modeling for quantification of tremor. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

New actigraph for long-term tremor recording. [2006]

12. England pubmed.ncbi.nlm.nih.gov

Quantifying upper limb tremor in people with multiple sclerosis using Fast Fourier Transform based analysis of wrist accelerometer signals. [2022]