Clinical trial NCT06257069: Tremor Retrainer Software Application for Functional Tremor
Official title: Tremor Retrainer Software Application for Functional Tremor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Movement Disorder
Functional Neurological Disorder
Functional Neurological Symptom Disorder
Keywords: Functional Tremor
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Child Neurology Foundation
First posted: 2024-02-13
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: mHealth Application Usability Questionnaire
timeFrame: Study visit 3
measure: Simplified Functional Movement Disorder Rating Scale
timeFrame: Study visits 1-4
Secondary outcomes:
Other outcomes:
measure: Adherence
timeFrame: Study visit 3
measure: Clinical Global Impression Severity Scale - Clinician Rated
timeFrame: Study visits 1-4
measure: Clinical Global Impression Improvement Scale - Clinician Rated
timeFrame: Study visits 2-4
measure: Clinical Global Impression Improvement Scale - Patient Rated
timeFrame: Study visits 2-4
measure: Visual Analog Scale
timeFrame: Between study visits 2-3
measure: 36-Item Short-Form Survey
timeFrame: Study visits 1 and 4
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Jordan Garris
role: PRINCIPAL_INVESTIGATOR
References: