Tremor Retrainer Software Application for Functional Tremor

Last updated: April 8, 2024
Sponsor: University of Virginia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tardive Dyskinesia

Anxiety Disorders

Dyskinesias

Treatment

Tremor Retrainer Smartphone Application

Clinical Study ID

NCT06257069
230161
  • Ages > 10
  • All Genders

Study 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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 10 years and older, any gender, any race
  2. Functional tremor as defined by Espay and Lang25, diagnosed by a movement disordersneurologist, involving at least 1 arm and ongoing at time of enrollment.
  3. Access to internet and a laptop or tablet with a videocamera.
  4. Informed consent obtained and signed
  5. Subject understands study procedures and is able to comply with study procedures forduration of study

Exclusion

Exclusion Criteria:

  1. Parkinson's disease, essential tremor, or other disorders causing involuntarymovements in addition to functional tremor
  2. Cognitive impairment with previously diagnosed intellectual disability (IQ<70) ordementia
  3. Hearing impairment not addressed by hearing aids
  4. Prior enrollment in clinical trial involving the Tremor Retrainer application

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Tremor Retrainer Smartphone Application
Phase:
Study Start date:
January 17, 2024
Estimated Completion Date:
January 17, 2026

Study 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.

Connect with a study center

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

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