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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06257069
Other study ID # 230161
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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