Demonstrating Efficacy of JOGO for the Treatment of Tremor
- Conditions
- Functional Neurological Disorder
- Interventions
- Device: JOGO
- Registration Number
- NCT06346873
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Clinical diagnosis of functional tremor diagnosed by a Mayo Clinic Florida movement disorders specialist.
- Must have access to reliable internet video.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JOGO for the Treatment of Tremor JOGO 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Tremor resolution 2 months 2-months post-treatment Number of subjects to experience tremor resolution on in-lab assessment
Tremor resolution 1 month 1-month post-treatment Number of subjects to experience tremor resolution on in-lab assessment
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 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 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).
Trial Locations
- Locations (1)
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States