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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06346873
Other study ID # 23-008090
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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