Functional Neurological DisorderNCT06346873
Demonstrating Efficacy of JOGO for the Treatment of Tremor
A study testing JOGO in people with Functional Neurological Disorder, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Neurological Disorder
- What is being tested?
- JOGO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2025to 3 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of functional tremor diagnosed by a Mayo Clinic Florida movement disorders specialist.
- Must have access to reliable internet video.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Functional Neurological Disorder
- Being tested
- JOGO
- Keywords
- Functional Tremor
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JOGODevice
AI driven mobile app and wearable sensors to provide virtual treatments
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: JOGO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1-month post-treatment
Secondary outcomes (8)
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.
Measured: Baseline, 2-month post-treatment
Change in QUEST scores
Measured by self-assessment with the Quality of Life in Essential Tremor Questionnaire (QUEST)
Measured: 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).
Measured: 2 months
Tremor resolution 1 month
Number of subjects to experience tremor resolution on in-lab assessment
Measured: 1-month post-treatment
Tremor resolution 2 months
Number of subjects to experience tremor resolution on in-lab assessment
Measured: 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.
Measured: 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.
Measured: Baseline, 1-month and 2-month post-treatment
Change in Intolerance of Uncertainty Scale
Measured: Baseline, 1-month and 2-month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start3 Jan 2025
- Primary completion3 Jan 2025
- Study completion3 Jan 2025
Why it stopped: PI No longer at Mayo Clinic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Neurological DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip Tipton, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346873
- Sponsor's protocol ID
- 23-008090
- Status last verified
- Dec 2025
- First submitted
- 29 Mar 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Demonstrate Efficacy of JOGO for the Treatment of Tremor
- ClinicalTrials.gov ID
- NCT06346873
- Acronym / sponsor ID
- 23-008090
- Conditions
- Functional Neurological Disorder
- Keywords
- Functional Tremor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI No longer at Mayo Clinic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JOGO for the Treatment of Tremor | Experimental | Device: JOGOSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of functional tremor diagnosed by a Mayo Clinic Florida movement disorders specialist.
- Must have access to reliable internet video.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JOGOAI driven mobile app and wearable sensors to provide virtual treatments | Device | JOGO for the Treatment of Tremor |
Primary outcome
Change in TETRAS scores 1 month
Time frame: Baseline, 1-month post-treatment
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.
8 secondary outcomes
Change in TETRAS scores 2 months
Time frame: Baseline, 2-month post-treatment
Change in QUEST scores
Time frame: Baseline, 1-month and 2-month post-treatment
Tremor prevalence
Time frame: 2 months
Tremor resolution 1 month
Time frame: 1-month post-treatment
Tremor resolution 2 months
Time frame: 2-months post-treatment
Change in BDI-II scores
Time frame: Baseline, 1-month and 2-month post-treatment
Change in BAI scores
Time frame: Baseline, 1-month and 2-month post-treatment
Change in Intolerance of Uncertainty Scale
Time frame: Baseline, 1-month and 2-month post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Tipton, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JOGO in people with Functional Neurological Disorder, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TETRAS scores 1 month (time frame: Baseline, 1-month post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.