Demonstrating Efficacy of JOGO for the Treatment of Tremor

NCT06346873 | Withdrawn FDA Device

• 1 other identifier: 23-008090
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Neurological Disorder

Keywords

Functional Tremor

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Change in TETRAS scores 2 months

  Baseline, 2-month post-treatment

• Change in QUEST scores

  Baseline, 1-month and 2-month post-treatment

• Tremor prevalence

  2 months

• Tremor resolution 1 month

  1-month post-treatment

• Tremor resolution 2 months

  2-months post-treatment

Study Arms (1)

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.

Device: JOGO

Interventions

JOGO DEVICE

AI driven mobile app and wearable sensors to provide virtual treatments

JOGO for the Treatment of Tremor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of functional tremor diagnosed by a Mayo Clinic Florida movement disorders specialist.
• Must have access to reliable internet video.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Philip Tipton, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: January 3, 2025
• Primary Completion: January 3, 2025
• Study Completion: January 3, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)