Functional Neurological Disorder
Conditions
Keywords
Functional Tremor
Brief summary
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.
Interventions
DEVICEJOGO
AI driven mobile app and wearable sensors to provide virtual treatments
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of functional tremor diagnosed by a Mayo Clinic Florida movement disorders specialist. * Must have access to reliable internet video.
Exclusion criteria
* Cognitive impairment (Montreal Cognitive Assessment greater than 26). * Currently taking any of the following medications to treat tremor: primidone, gabapentin, zonisamide, any non-selective beta blocker, any benzodiazepine. * Exposure to tremorgenic drugs or drug with withdrawal states within 30 days prior to the study start. * Direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor. * Known history of other medical or neurological conditions that may cause or explain subject's tremor, including, but not limited to: Parkinson's disease, dystonia, cerebellar disease, traumatic brain injury, alcohol abuse or withdrawal, mercury poisoning, hyperthyroidism, pheochromocytoma, head trauma or cerebrovascular disease within 3 months prior to the onset of essential tremor, multiple sclerosis, polyneuropathy, family history of Fragile X syndrome. * Prior MR-guided focused ultrasound or surgical intervention (e.g., deep brain stimulation, ablative thalamotomy or gamma knife thalamotomy). * Botulinum toxin injection in the 6 months prior to screening. * Use of medication(s) in the past month that might produce tremor or interfere with the evaluation of tremor, such as, but not limited to: CNS-stimulants, lithium, amiodarone, metoclopramide, theophylline, and valproate. * Regular use of more than two units of alcohol per day. * Sporadic use of a benzodiazepine, sleep medication or anxiolytic to improve sleep performance. Stable use at a consistent dose is allowed if tremor persists against the background of regular medication use. * Current treatment with any investigational therapy for tremor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in TETRAS scores 1 month | Baseline, 1-month post-treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in QUEST scores | Baseline, 1-month and 2-month post-treatment | Measured by self-assessment with the Quality of Life in Essential Tremor Questionnaire (QUEST) |
| Tremor prevalence | 2 months | Number of tremors in time awake during the day measured by wearable device system (KinesiaUTM). |
| Tremor resolution 1 month | 1-month post-treatment | Number of subjects to experience tremor resolution on in-lab assessment |
| Change in TETRAS scores 2 months | Baseline, 2-month post-treatment | 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. |
| Change in BDI-II scores | Baseline, 1-month and 2-month post-treatment | 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. |
| Change in BAI scores | Baseline, 1-month and 2-month post-treatment | 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. |
| Change in Intolerance of Uncertainty Scale | Baseline, 1-month and 2-month post-treatment | — |
| Tremor resolution 2 months | 2-months post-treatment | Number of subjects to experience tremor resolution on in-lab assessment |
Countries
United States
Outcome results
None listed