Tremor Retrainer Software Application for Functional Tremor

Functional Neurological Disorder Clinical Trial

Official title:

Tremor Retrainer Software Application for Functional Tremor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257069
• Other study ID #: 230161
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2024
• Est. completion date: January 17, 2026

Study information

• Verified date: April 2024
• Source: University of Virginia
• Contact: Hannah Caballero, LCSW
• Phone: 434-297-5711
• Email: HTP5AW[@]uvahealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 17, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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 disorders neurologist, 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 for duration of study

Exclusion Criteria:

1. Parkinson's disease, essential tremor, or other disorders causing involuntary movements in addition to functional tremor

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

3. Hearing impairment not addressed by hearing aids

4. Prior enrollment in clinical trial involving the Tremor Retrainer application

Related Conditions & MeSH terms

• Conversion Disorder
• Functional Movement Disorder
• Functional Neurological Disorder
• Functional Neurological Symptom Disorder
• Movement Disorders
• Nervous System Diseases
• Tremor

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Child Neurology Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence	Duration of sessions completed	Study visit 3
Other	Clinical Global Impression Severity Scale - Clinician Rated	Clinician rated impression of tremor severity. Score range: 1-7, with 7 being most severely affected	Study visits 1-4
Other	Clinical Global Impression Improvement Scale - Clinician Rated	Clinician rated impression of tremor change. Score range: 1-7, with 1 being best and 7 being worst.	Study visits 2-4
Other	Clinical Global Impression Improvement Scale - Patient Rated	Patient rated impression of tremor change. Score range: 1-7, with 1 being best and 7 being worst.	Study visits 2-4
Other	Visual Analog Scale	Patient rated impression of tremor severity. Score range: 0-10, with 10 being worst tremor imaginable.	Between study visits 2-3
Other	36-Item Short-Form Survey	Quality of life scale. Score range: 0-100, with 100 being best.	Study visits 1 and 4
Primary	mHealth Application Usability Questionnaire	Usability Questionnaire. Score range: 21-147 with higher scores indicating better usability	Study visit 3
Primary	Simplified Functional Movement Disorder Rating Scale	Videorecorded severity scale. Score range: 0-54 with higher scores indicating greater severity (worse movements)	Study visits 1-4