Demonstrating Efficacy of JOGO for the Treatment of Tremor

Pilot Study to Demonstrate Efficacy of JOGO for the Treatment of Tremor

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.

Study Overview

• Status: Withdrawn
• Conditions: Functional Neurological Disorder
• Intervention / Treatment: Device: JOGO

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JOGO for the Treatment of Tremor; 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; AI driven mobile app and wearable sensors to provide virtual treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in TETRAS scores 2 months	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, 2-month post-treatment
Change in QUEST scores	Measured by self-assessment with the Quality of Life in Essential Tremor Questionnaire (QUEST)	Baseline, 1-month and 2-month post-treatment
Tremor prevalence	Number of tremors in time awake during the day measured by wearable device system (KinesiaUTM).	2 months
Tremor resolution 1 month	Number of subjects to experience tremor resolution on in-lab assessment	1-month post-treatment
Tremor resolution 2 months	Number of subjects to experience tremor resolution on in-lab assessment	2-months post-treatment
Change in BDI-II scores	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.	Baseline, 1-month and 2-month post-treatment
Change in BAI scores	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.	Baseline, 1-month and 2-month post-treatment
Change in Intolerance of Uncertainty Scale		Baseline, 1-month and 2-month post-treatment

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Philip Tipton, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2025
• Primary Completion (Actual): January 3, 2025
• Study Completion (Actual): January 3, 2025

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Functional Tremor
• Additional Relevant MeSH Terms: Mental Disorders; Somatoform Disorders; Conversion Disorder
• Other Study ID Numbers: 23-008090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No