NCT06257069

Tremor Retrainer Software Application for Functional Tremor

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

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?

Detailed description

Following a one-week observation period, 20 subjects will complete the one-week four hour Tremor Retrainer smartphone protocol. The study will consist of 4 in-person visits over 3-4 months and one televideo visit the same day as study visit 1. For Objective 1, the investigators will evaluate mHealth Application Usability Questionnaire scores after subjects complete Tremor Retrainer protocol and compare Simplified Functional Movement Disorder Rating Scale (S-FMDRS) scores before (study visit 2) and after (study visits 3 and 4) intervention between groups. For Objective 2, the investigators will evaluate which components can be scored after televideo administration of S-FMDRS and measure correlation between randomly-ordered sequential in-person and televideo S-FMDRS administration. For Objective 3, the investigators will measure change and variability in S-FMDRS between study visit 1 and 2. S-FMDRS scoring will be completed via video review by a movement disorder neurologist blinded to timing of visit relative to treatment.

Conditions

• Functional Movement Disorder
• Functional Neurological Disorder
• Functional Neurological Symptom Disorder

Interventions

Type	Name	Description
DEVICE	Tremor Retrainer Smartphone Application	The Tremor Retrainer smartphone application uses the smartphone's built-in accelerometer to calculate a patient's tremor frequency when the smartphone is strapped to the patient's wrist. The application will provide auditory cues to the patient with a treatment frequency at 2/3 the patient's baseline tremor frequency for half a session, then 1/3 the patient's baseline tremor frequency for the second half of the session. Meanwhile, oscillatory movements will be continuously analyzed with frequency calculated and displayed relative to goal frequency, so that the patient receives continuous feedback via a visual dial as to whether they are meeting treatment goals. Intervention will consist of a one-week Tremor Retrainment Protocol.

Timeline

• Start date: 2024-01-17
• Primary completion: 2025-10-31
• Completion: 2026-01-17
• First posted: 2024-02-13
• Last updated: 2024-04-10

Locations

1 site across 1 country: United States