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Active, Not Recruiting

NCT Number: NCT06257069

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 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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Functional Movement Disorder Conversion Disorder Functional Neurological Disorder Functional Neurological Symptom Disorder Mental Disorders Somatoform Disorders

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati, Cincinnati, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 10 years and older, any gender, any race
  • 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.
  • Access to internet and a laptop or tablet with a videocamera.
  • Informed consent obtained and signed
  • Subject understands study procedures and is able to comply with study procedures for duration of study

Exclusion criteria

  • Parkinson's disease, essential tremor, or other disorders causing involuntary movements in addition to functional tremor
  • Cognitive impairment with previously diagnosed intellectual disability (IQ<70) or dementia
  • Hearing impairment not addressed by hearing aids
  • Prior enrollment in clinical trial involving the Tremor Retrainer application

Treatment and study plan

Tremor Retrainer Smartphone Application

Device

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.

Primary outcomes

  1. mHealth Application Usability Questionnaire

    Time frame: Study visit 3

    Usability Questionnaire. Score range: 21-147 with higher scores indicating better usability

  2. Simplified Functional Movement Disorder Rating Scale

    Time frame: Study visits 1-4

    Videorecorded severity scale. Score range: 0-54 with higher scores indicating greater severity (worse movements)

Other outcomes

  1. Adherence

    Time frame: Study visit 3

    Duration of sessions completed

  2. Clinical Global Impression Severity Scale - Clinician Rated

    Time frame: Study visits 1-4

    Clinician rated impression of tremor severity. Score range: 1-7, with 7 being most severely affected

  3. Clinical Global Impression Improvement Scale - Clinician Rated

    Time frame: Study visits 2-4

    Clinician rated impression of tremor change. Score range: 1-7, with 1 being best and 7 being worst.

  4. Clinical Global Impression Improvement Scale - Patient Rated

    Time frame: Study visits 2-4

    Patient rated impression of tremor change. Score range: 1-7, with 1 being best and 7 being worst.

  5. Visual Analog Scale

    Time frame: Between study visits 2-3

    Patient rated impression of tremor severity. Score range: 0-10, with 10 being worst tremor imaginable.

  6. 36-Item Short-Form Survey

    Time frame: Study visits 1 and 4

    Quality of life scale. Score range: 0-100, with 100 being best.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Child Neurology Foundation

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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