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NCT06346873 | NOT YET RECRUITING | Functional Neurological Disorder

Demonstrating Efficacy of JOGO for the Treatment of Tremor
Sponsor:

Mayo Clinic

Information provided by (Responsible Party):

Philip W. Tipton

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.

Condition or disease

Functional Neurological Disorder

Intervention/treatment

JOGO

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Pilot Study to Demonstrate Efficacy of JOGO for the Treatment of Tremor
Actual Study Start Date : 2025-11
Estimated Primary Completion Date : 2026-09
Estimated Study Completion Date : 2027-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Demonstrating Efficacy of JOGO for the Treatment of Tremor

Location Details

NCT06346873

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How to Participate

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Locations

Not yet recruiting

United States, Florida

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224