Functional Movement Disorder, Functional Neurological Disorder, Functional Neurological Symptom Disorder
Conditions
Keywords
Functional Tremor
Brief 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?
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.
Interventions
DEVICETremor 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.
Sponsors
University of Virginia
Child Neurology Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mHealth Application Usability Questionnaire | Study visit 3 | Usability Questionnaire. Score range: 21-147 with higher scores indicating better usability |
| Simplified Functional Movement Disorder Rating Scale | Study visits 1-4 | Videorecorded severity scale. Score range: 0-54 with higher scores indicating greater severity (worse movements) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJordan Garris
University of Virginia
Outcome results
None listed