Demonstrating Efficacy of JOGO for the Treatment of Tremor

Mayo Clinic

Status: Begins enrollment in 5 months

Conditions: Functional Neurological Disorder

Treatments: Device: JOGO

Study type: Interventional

Funder types: Other

Identifiers

NCT06346873

23-008090

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

JOGO for the Treatment of Tremor

Experimental group

Description:

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.

Treatment:

Device: JOGO