Functional Movement DisorderNCT06257069
Tremor Retrainer Software Application for Functional Tremor
A study testing Tremor Retrainer Smartphone Application in people with Functional Movement Disorder and Functional Neurological Disorder, run by University of Virginia at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Functional Movement Disorder, Functional Neurological Disorder, Functional Neurological Symptom Disorder
- What is being tested?
- Tremor Retrainer Smartphone Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jan 2024to 1 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 10 years and older, any gender, any race
- 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.
- Access to internet and a laptop or tablet with a videocamera.
- Informed consent obtained and signed
- Subject understands study procedures and is able to comply with study procedures for duration of study
Who cannot join
- Parkinson's disease, essential tremor, or other disorders causing involuntary movements in addition to functional tremor
- Cognitive impairment with previously diagnosed intellectual disability (IQ<70) or dementia
- Hearing impairment not addressed by hearing aids
- Prior enrollment in clinical trial involving the Tremor Retrainer application
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia
Charlottesville, Virginia, 22903
University of Cincinnati
Cincinnati, Ohio, 45219
About this study
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:
- Is the Tremor Retrainer application usable for patients and are there signs that it can help functional tremor?
- Can a televideo administration of the Simplified Functional Movement Disorder Rating Scale give enough information to use this scale via televideo in future studies?
Read the 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.
- Conditions
- Functional Movement Disorder, Functional Neurological Disorder, Functional Neurological Symptom Disorder
- Being tested
- Tremor Retrainer Smartphone Application
- Keywords
- Functional Tremor
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tremor Retrainer Smartphone ApplicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | All subjects will receive intervention with Tremor Retrainer smartphone application Receives: Device: Tremor Retrainer Smartphone Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
mHealth Application Usability Questionnaire
Usability Questionnaire. Score range: 21-147 with higher scores indicating better usability
Measured: Study visit 3
Simplified Functional Movement Disorder Rating Scale
Videorecorded severity scale. Score range: 0-54 with higher scores indicating greater severity (worse movements)
Measured: Study visits 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start17 Jan 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Movement DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Child Neurology Foundation
- Responsible party
- Principal investigator, Jordan F Garris, University of Virginia
- Investigators
- Jordan Garris, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257069
- Sponsor's protocol ID
- 230161
- Status last verified
- May 2026
- First submitted
- 5 Feb 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized participant data, including raw scores of outcome measures will be available for review.