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?

Study Overview

• Status: Recruiting
• Conditions: Functional Neurological Symptom Disorder; Functional Neurological Disorder; Functional Movement Disorder
• Intervention / Treatment: Device: Tremor Retrainer Smartphone Application

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah Caballero, LCSW; Phone Number: 434-297-5711; Email: HTP5AW@uvahealth.org

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Contact: Hannah Caballero, LCSW; Phone Number: 434-297-5711; Email: HTP5AW@uvahealth.org
      • Principal Investigator: Jordan Garris, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention Arm; All subjects will receive intervention with Tremor Retrainer smartphone application

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mHealth Application Usability Questionnaire	Usability Questionnaire. Score range: 21-147 with higher scores indicating better usability	Study visit 3
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Duration of sessions completed	Study visit 3
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
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
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
Visual Analog Scale	Patient rated impression of tremor severity. Score range: 0-10, with 10 being worst tremor imaginable.	Between study visits 2-3
36-Item Short-Form Survey	Quality of life scale. Score range: 0-100, with 100 being best.	Study visits 1 and 4

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Child Neurology Foundation
• Investigators: Principal Investigator: Jordan Garris, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): January 17, 2026

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Functional Tremor
• Additional Relevant MeSH Terms: Mental Disorders; Central Nervous System Diseases; Neurologic Manifestations; Personality Disorders; Dyskinesias; Somatoform Disorders; Histrionic Personality Disorder; Nervous System Diseases; Movement Disorders; Tremor; Conversion Disorder; Hysteria
• Other Study ID Numbers: 230161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized participant data, including raw scores of outcome measures will be available for review.
• IPD Sharing Time Frame: Data anticipated to be available in 2026.
• IPD Sharing Access Criteria: Anonymized participant data will be publicly available.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No