Demonstrating Efficacy of JOGO for the Treatment of Tremor

Functional Neurological Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06346873
• Other study ID #: 23-008090
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2027

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Audrey Strongosky
• Phone: 904-953-8308
• Email: Strongosky.Audrey2[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Conversion Disorder
• Functional Neurological Disorder
• Nervous System Diseases
• Tremor

Intervention

Device:
• JOGO
AI driven mobile app and wearable sensors to provide virtual treatments

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Tremor prevalence	Number of tremors in time awake during the day measured by wearable device system (KinesiaUTM).	2 months
Secondary	Tremor resolution 1 month	Number of subjects to experience tremor resolution on in-lab assessment	1-month post-treatment
Secondary	Tremor resolution 2 months	Number of subjects to experience tremor resolution on in-lab assessment	2-months post-treatment
Secondary	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
Secondary	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
Secondary	Change in Intolerance of Uncertainty Scale		Baseline, 1-month and 2-month post-treatment