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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app designed to help individuals with functional tremor, a type of shaking not caused by another known disorder. The study aims to determine if the app, called the Tremor Retrainer Software Application, is user-friendly and shows potential in reducing tremors. It will also assess the effectiveness of using a simple movement rating scale over video calls. Individuals with an ongoing functional tremor in at least one arm, who have internet access and a device with a camera, might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new ways to manage functional tremor.

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 prior data suggests that the Tremor Retrainer smartphone application is safe for patients with functional tremor?

Research has shown that the Tremor Retrainer smartphone app is easy for patients to use. Past studies found no major side effects. The app uses the phone's sensor to monitor tremor frequency and provides sound cues to help manage them. As a software app, it doesn't require medication or physical treatments, reducing the risk of side effects. Being non-invasive, it doesn't alter the body or require surgery. This makes it a safe option for those seeking to manage tremors without traditional medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Tremor Retrainer App is unique because it offers a non-invasive, digital approach to managing tremors, unlike traditional medications like beta-blockers or antiepileptic drugs. This smartphone application provides personalized exercises and feedback, which can be more convenient and accessible for users. Researchers are excited about its potential to empower patients with real-time management tools and possibly reduce reliance on pharmaceuticals, offering a new way to address tremors that focuses on retraining the brain's control over muscle movements.

What evidence suggests that the Tremor Retrainer app is effective for functional tremor?

Research shows that the Tremor Retrainer smartphone app, provided to all trial participants, may help manage functional tremors. This app uses sound cues to help users steady their tremors. Early studies have shown that these sound cues can positively alter the tremor. Additionally, smartphone apps have effectively measured and monitored tremors, providing clear and accurate information. While more research is needed, these early results suggest the app could be a promising tool for those with functional tremors. ^{1 2 3 4 5}

Who Is on the Research Team?

Jordan Garris

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

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.

Functional tremor as defined by Espay and Lang25, diagnosed by a movement disorders neurologist, involving at least 1 arm and ongoing at time of enrollment

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06257069?cond=functional%20movement%20disorders&aggFilters=status:not%20rec,ages:child&viewType=Table&rank=1

Tremor Retrainer Software Application for Functional Tremor The purpose of this clinical trial is to learn about the Tremor Retrainer smartphone application and Simplified Functional Movement Disorder Rating Scale in ...

2. withpower.com withpower.com/trial/phase-hysteria-2024-b7b59

Tremor Retrainer App for Tremors Research shows that smartphone applications can effectively measure and assess tremors, as they provide objective and quantitative evaluations similar to ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38145279/

Development and Pilot Testing of the Tremor Retrainer ... The Tremor Retrainer smartphone application modulates functional tremor frequency by providing pulsed auditory cues for a patient to match ...

4. tremorjournal.org tremorjournal.org/articles/10.5334/tohm.823

Development and Pilot Testing of the Tremor Retrainer ... Highlights: The Tremor Retrainer smartphone application modulates functional tremor frequency by providing pulsed auditory cues for a patient to ...

5. trialx.com trialx.com/clinical-trials/listings/284998/tremor-retrainer-software-application-for-functional-tremor/

Tremor Retrainer Software Application for Functional Tremor The purpose of this clinical trial is to learn about the Tremor Retrainer smartphone application and Simplified Functional Movement Disorder ...