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PI No longer at Mayo Clinic
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This research is being done to determine the effectiveness of a new treatment, called JOGO, for patients with functional tremor (FT). JOGO is a biofeedback device that has been shown to help patients with several conditions, e.g., chronic pain, migraine, and Parkinson's disease (PD)-related tremor. JOGO provides biofeedback by using wireless adhesive stickers, called surface electromyography, to get information about muscle activity. This information is then used to modify symptoms through a series of training sessions with a physical therapist and individual practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JOGO for the Treatment of Tremor | Experimental | Subjects with a diagnosis of essential tremor (ET) or functional tremor (FT) involving one or more of the upper extremities will undergo a 12-week JOGO treatment program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JOGO | Device | AI driven mobile app and wearable sensors to provide virtual treatments |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in TETRAS scores 1 month | Assessment with The Essential Tremor Rating Assessment Scale (TETRAS), consists of ten items in which action tremor is rated 0-4 in half-point increments by a clinician. Greater total scores indicate worse action tremor. | Baseline, 1-month post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TETRAS scores 2 months | Assessment with The Essential Tremor Rating Assessment Scale (TETRAS), consists of ten items in which action tremor is rated 0-4 in half-point increments by a clinician. Greater total scores indicate worse action tremor. | Baseline, 2-month post-treatment |
| Change in QUEST scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Tipton, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D003291 | Conversion Disorder |
| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
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Measured by self-assessment with the Quality of Life in Essential Tremor Questionnaire (QUEST) |
| Baseline, 1-month and 2-month post-treatment |
| Tremor prevalence | Number of tremors in time awake during the day measured by wearable device system (KinesiaUTM). | 2 months |
| Tremor resolution 1 month | Number of subjects to experience tremor resolution on in-lab assessment | 1-month post-treatment |
| Tremor resolution 2 months | Number of subjects to experience tremor resolution on in-lab assessment | 2-months post-treatment |
| Change in BDI-II scores | Assessment with the Beck Depression Index II (BDI-II) questionnaire to assess depression severity, a 21-item scale, with items ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. | Baseline, 1-month and 2-month post-treatment |
| Change in BAI scores | Assessment with the Beck Anxiety Index (BAI) that measures the severity of anxiety symptoms. Possible scores range from 0 to 63 with higher scores indicating a worse outcome/more severe symptoms of anxiety. | Baseline, 1-month and 2-month post-treatment |
| Change in Intolerance of Uncertainty Scale | Baseline, 1-month and 2-month post-treatment |