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| Name | Class |
|---|---|
| Child Neurology Foundation | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | All subjects will receive intervention with Tremor Retrainer smartphone application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tremor Retrainer Smartphone Application | Device | 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. |
| 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 |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordan Garris | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States | ||
| University of Virginia |
Anonymized participant data, including raw scores of outcome measures will be available for review.
Data anticipated to be available in 2026.
Anonymized participant data will be publicly available.
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| ID | Term |
|---|---|
| D003291 | Conversion Disorder |
| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
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| 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 |
| Charlottesville |
| Virginia |
| 22903 |
| United States |