Tremor Retrainer App for Tremors

Overseen By Hannah Caballero, LCSW

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Parkinson's, Essential tremor, Dementia, others

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

Compensation: Varies

Number of Visits: 9

Duration: 1 week

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Tremor Retrainer App treatment for tremors?

Research shows that smartphone applications can effectively measure and assess tremors, as they provide objective and quantitative evaluations similar to clinical tools. These apps have been used successfully in Parkinson's disease to assess tremor, suggesting potential for similar effectiveness in other tremor-related conditions. ^{1 2 3 4 5}

Is the Tremor Retrainer App safe for use in humans?

The available research on mobile applications for tremor assessment, particularly in Parkinson's disease, suggests that these apps are generally safe to use, as they have been validated against clinical scales and laboratory equipment. However, specific safety validation studies for the Tremor Retrainer App itself are not mentioned. ^{1 2 4 5 6}

How is the Tremor Retrainer App treatment different from other treatments for tremors?

The Tremor Retrainer App is unique because it uses a smartphone application to assess and potentially retrain tremors, leveraging the phone's built-in sensors like accelerometers and gyroscopes. This approach offers a more accessible, cost-effective, and objective way to evaluate and manage tremors compared to traditional methods that often require expensive and bulky equipment. ^{1 4 5 7 8}

What is the purpose of this trial?

The purpose of this clinical trial is to learn about the Tremor Retrainer smartphone application and Simplified Functional Movement Disorder Rating Scale in patients with functional tremor. The main questions the study aims to answer are: 1. Is the Tremor Retrainer application usable for patients and are there signs that it can help functional tremor? 2. Can a televideo administration of the Simplified Functional Movement Disorder Rating Scale give enough information to use this scale via televideo in future studies?

Research Team

Jordan Garris

Principal Investigator

University of Virginia

Eligibility Criteria

This trial is for individuals with functional tremor and related conditions like hysteria, movement disorders, or conversion disorder. Participants should be able to use a smartphone application designed to help manage their tremor.

Inclusion Criteria

I understand and can follow the study's procedures.

I am 10 years old or older.

Informed consent obtained and signed

Exclusion Criteria

Cognitive impairment with previously diagnosed intellectual disability (IQ<70) or dementia

New treatment planned to begin before study visit 3

Hearing impairment not addressed by hearing aids

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (televideo)

Observation

Participants undergo a one-week observation period before starting the intervention

1 week

Treatment

Participants complete the one-week four-hour Tremor Retrainer smartphone protocol

1 week

4 visits (in-person), 1 visit (televideo)

Follow-up

Participants are monitored for changes in tremor severity and usability of the application

3-4 months

4 visits (in-person)

Treatment Details

Interventions

• Tremor Retrainer Software Application

Trial Overview The study tests the Tremor Retrainer app's usability and effectiveness in managing functional tremors. It also evaluates if the Simplified Functional Movement Disorder Rating Scale can be reliably used through televideo for future research.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

All subjects will receive intervention with Tremor Retrainer smartphone application

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Child Neurology Foundation

Collaborator

Trials

3

Recruited

580+

Findings from Research

A systematic review identified 14 studies and 13 mobile applications that can assess resting tremor in Parkinson's disease patients using smartphone sensors, indicating a growing interest in digital health tools for this condition.

While the mobile apps showed a high adherence to medical development recommendations (85.09%), there is a need for more validation studies to confirm their effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Applications for Resting Tremor Assessment in Parkinson's Disease: A Systematic Review. Moreta-de-Esteban, P., Martín-Casas, P., Ortiz-Gutiérrez, RM., et al.[2023]

The study evaluated a mobile health application designed to improve gait, speech, and dexterity in people with Parkinson's disease over 12 weeks, but found that adherence to the app was moderate and did not lead to significant improvements in these areas.

Overall, the mHealth application was deemed ineffective in its current form for treating symptoms of Parkinson's disease, as there were no significant changes in the primary outcome measures and weak correlations between app usage and symptom improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of a daily mHealth application designed to address mobility, speech and dexterity in Parkinson's disease. Horin, AP., McNeely, ME., Harrison, EC., et al.[2020]

A smartphone-based tool using accelerometer and gyroscope data can accurately assess upper limb tremor in Parkinson's disease patients, achieving an 82% classification accuracy for patients and 90% for healthy volunteers in a study of 25 patients and 20 controls.

This low-cost, noninvasive tool is easy to use and can assist physicians in monitoring patients remotely, potentially improving daily communication and ongoing research into Parkinson's disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone-Based Tool for Assessing Parkinsonian Hand Tremor. Kostikis, N., Hristu-Varsakelis, D., Arnaoutoglou, M., et al.[2016]

A smartphone application was successfully developed and validated to assess tremor, making it easier to study this common movement disorder in large populations.

The app's data was compared with laboratory equipment and clinical scales, confirming its reliability and clinical relevance for characterizing tremor properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring tremor with a smartphone. Carignan, B., Daneault, JF., Duval, C.[2022]

The TREMOR12 app is an innovative open-source tool that quantifies tremor characteristics like acceleration and rotation in a user-friendly manner, making it easier to evaluate treatment effects in patients with essential tremor.

This app complies with regulatory standards from the European Union and the FDA, ensuring its safety and potential for use in both research and clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TREMOR12: An Open-Source Mobile App for Tremor Quantification. Kubben, PL., Kuijf, ML., Ackermans, LP., et al.[2018]

A custom smartphone application was tested on 14 Parkinson's disease patients and showed a significant correlation with established clinical scales (MDS-UPDRS), indicating its potential for accurately assessing motor symptoms like tremor and bradykinesia.

The study suggests that smartphones could serve as a convenient and low-cost tool for objectively monitoring motor symptoms in Parkinson's disease, which could enhance both clinical assessments and research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Tool for Remote Digital Assessment of Parkinson's Disease. Kassavetis, P., Saifee, TA., Roussos, G., et al.[2022]

The Itremor smartphone application effectively quantifies tremor severity in patients with essential tremor, showing good correlation with traditional clinical scores, which can be subjective and variable.

Using Itremor provides a more objective and reproducible assessment of tremor compared to clinical evaluations, potentially improving treatment adjustments for patients receiving deep brain stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Accelerometers Integrated in Smartphones to Evaluate Essential Tremor. Senova, S., Querlioz, D., Thiriez, C., et al.[2022]

The iSeismo application on an iPhone can effectively measure tremor frequency, providing a more accessible and efficient alternative to traditional, expensive equipment.

In a preliminary study involving 7 different tremor cases, the frequency measurements obtained from the iSeismo app closely matched those from sophisticated EMG analysis, suggesting its potential utility in clinical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid tremor frequency assessment with the iPhone accelerometer. Joundi, RA., Brittain, JS., Jenkinson, N., et al.[2017]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Mobile Applications for Resting Tremor Assessment in Parkinson's Disease: A Systematic Review. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Usability of a daily mHealth application designed to address mobility, speech and dexterity in Parkinson's disease. [2020]

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

A Smartphone-Based Tool for Assessing Parkinsonian Hand Tremor. [2016]

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

Measuring tremor with a smartphone. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

TREMOR12: An Open-Source Mobile App for Tremor Quantification. [2018]

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

Developing a Tool for Remote Digital Assessment of Parkinson's Disease. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Using the Accelerometers Integrated in Smartphones to Evaluate Essential Tremor. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Rapid tremor frequency assessment with the iPhone accelerometer. [2017]