Clinical trial NCT06346873: Demonstrating Efficacy of JOGO for the Treatment of Tremor
Official title: Pilot Study to Demonstrate Efficacy of JOGO for the Treatment of Tremor
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Functional Neurological Disorder
Keywords: Functional Tremor
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in TETRAS scores 1 month
timeFrame: Baseline, 1-month post-treatment
Secondary outcomes:
measure: Change in TETRAS scores 2 months
timeFrame: Baseline, 2-month post-treatment
measure: Change in QUEST scores
timeFrame: Baseline, 1-month and 2-month post-treatment
measure: Tremor prevalence
timeFrame: 2 months
measure: Tremor resolution 1 month
timeFrame: 1-month post-treatment
measure: Tremor resolution 2 months
timeFrame: 2-months post-treatment
measure: Change in BDI-II scores
timeFrame: Baseline, 1-month and 2-month post-treatment
measure: Change in BAI scores
timeFrame: Baseline, 1-month and 2-month post-treatment
measure: Change in Intolerance of Uncertainty Scale
timeFrame: Baseline, 1-month and 2-month post-treatment
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Philip Tipton, MD
role: PRINCIPAL_INVESTIGATOR
References: