Essential TremorNCT05958030
GyroGlove Use in Essential Tremor Patients
A study testing GyroGlove in people with Essential Tremor, run by GyroGear Ltd at 7 sites in 2 countries.
Trial summary
This is a multi-centre, single-blind, placebo-controlled trial with an open label follow up. After the baseline assessment, all participants will receive the GyroGlove for two weeks during the open label follow up part of the trial. All gloves will be retrieved and returned to GyroGear after closure of the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- GyroGlove
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jul 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years of age or older
- Subject has been clinically diagnosed with ET
- Has either unilateral or bilateral tremor of the hand or predominantly hand as well as forearm
- Has a score of ≥ 2 in ADL activities 2, 3, 6 \& 8 of the TETRAS ADL subscale (TRG, Sep 2021)
- Tremor in at least one hand causing water spillage during drinking
- And
Show all 11Show fewer
- Stable dosage of medications throughout the duration of the study, if applicable
- Ability to speak and read in the language that the trial documentation has been translated to.
- Ability to understand verbal instructions in the language that the trial documentation has been translated to.
- Ability to provide written informed consent to participate in the study
- Capacity to complete self-report outcome measures in the language that the trial documentation has been translated to
Who cannot join
- Other possible causes of tremor, including Parkinson's disease, drug-induced, enhanced physiological tremor
- Presence of tremor around the elbow and shoulder limiting participants to perform required test/procedure in the study
- Has implanted electrical medical device, e.g., pacemaker, defibrillator, or deep brain stimulator
- Clinically diagnosed alcohol use disorder or illicit substance use (exception medical cannabis)
- Change in medication for tremor within 1 month prior to study enrolment
- Change in antidepressant medication within 3 months prior to study enrolment
Show all 18Show fewer
- Has received botulinum toxin injection for hand tremor within 4 months prior to study enrolment
- Has been diagnosed with any of the following conditions affecting the hand and/or arm:
- Fingers/Wrist joint defects or deformities or current skeletal injuries that prevent them from wearing the glove
- Hand muscular deformities or weakness, e.g.: Myotonic Dystrophy, Autosomal Recessive Muscular Dystrophy limiting participant to perform required test/procedure in the study
- Skin Conditions of the hand and forearm, e.g.: Eczema, Psoriasis, Extreme Skin Sensitivity
- Growth or Development Defects of the hand, including but not limited to, Brittle Bone Disease, Triphalangeal Thumb.
- Previous thalamotomy procedure, including stereotactic thalamotomy, gamma knife radio surgical thalamotomy, and focused ultrasound for the treatment of tremor.
- Neurological conditions aside from essential tremor that may affect the conduct of the study
- Peripheral neuropathy affecting the upper extremity
- Are participating or have participated in any interventional clinical trial or study in the last 30 days which may confound the results of this study, unless approved by the Sponsor
- Inability to follow simple instructions
- Pregnancy
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
United Kingdom4 sites
Addenbrooke Hospital, Cambridge University Hospital NHS Trust
Cambridge, England, CB2 0QQ
Paul Worth, 01223349289, paul.worth@addenbrookes.nhs.uk
Clinical Ageing Research Unit, Newcastle University
Newcastle, England, NE4 5PL
Nicola Pavese, 0191 2081264, nicola.pavese@newcastle.ac.uk
North Tyneside General Hospital
Newcastle, NE29 8NH
Richard Walker, 07795617590, Richard.Walker@northumbria-healthcare.nhs.uk
Oxford University Hospitals NHS Foundation Trust, UK
Oxford, England, OX3 9DU
Raj Sarangmat, 07912145463, Nagaraja.Sarangmat@ouh.nhs.uk
United States3 sites
University of Vermont Medical Centre
Burlington, Vermont, 05401
James Boyd, 802-847-4589, James.Boyd@uvmhealth.org
Quest Research Institute
Farmington Hills, Michigan, 48334
Peter LeWitt, 248-957-8940, peter@questri.com
Houston Methodist Stanley H. Appel Department of Neurology
Houston, Texas, 77030
William Ondo, 346-238-9068, wondo@houstonmethodist.org
About this study
Official title: Effectiveness and Safety of GyroGlove in Stabilising Hand Tremors in Essential Tremor
This is a multi-centre, single-blind, placebo-controlled trial with an open label follow up. After the baseline assessment, all participants will receive the GyroGlove for two weeks during the open label follow up part of the trial. All gloves will be retrieved and returned to GyroGear after closure of the study.
Read the detailed description
All participants will attend 2 in-clinic assessment sessions (Baseline (day 0), Follow-up (day 14)) after screening visit. The baseline session will last approximately 120 minutes whilst the 2-week assessment will last approximately 60-80 minutes. At baseline assessment, participants will perform protocol-specific activities with both investigational devices (i.e. GyroGlove and Placebo).
In addition to in-clinic assessments, participants will complete self-assessments at Day -3 prior baseline visit (i.e. Day 0,) and at Day 5 and 10 from baseline (i.e. Day 0), when they started using GyroGlove at home.
All participants will be blinded at the baseline (Day 0), as assessments will be performed with GyroGlove and a placebo device in a pre-defined sequence. Each participant will act as the control for him/herself and will be blinded to the interventions order.
The sequence of interventions in the study has been pre-defined, owing to the potential for longitudinal effects of wearing the device interfering with the accurate study outcome measurement.
- Conditions
- Essential Tremor
- Being tested
- Placebo, GyroGlove
- Keywords
- Essential Tremor, Activities of Daily Living
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDevice
The placebo device consists of the same hardware as GyroGlove: aesthetically it looks the same, weight same and produces the same noise as GyroGlove. Participants will interact with Placebo on the day of baseline visit (i.e. Day 0).
GyroGloveDevice
GyroGlove is a patented wearable device containing high-performance, miniaturised, gyroscopes designed for individuals diagnosed with essential tremor. Participants will interact with GyroGlove on the day of baseline visit (i.e. Day 0), 2-week Home use and on the day of follow-up visit (i.e Day 14).
| Study group | Role | What they receive |
|---|---|---|
| No Interventional | No intervention | Participants will perform protocol-specific tasks with no device |
| Investigational Device Arm | Experimental | GyroGlove Receives: Device: GyroGlove |
| Placebo Arm | Placebo comparator | Placebo Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week- 2 (follow-up assessment) on The Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score performance in ET participants
The Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score is the sum of modified items 2, 3, 6 \& 8 of the TETRAS-ADL (Activities of Daily Living) subscale and modified items 6 - 7 of the TETRAS-PS (performance subscale). The TETRAS-ADL subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as feeding with a spoon, drinking from a glass, pouring, using keys etc. The TETARS-PS is a clinical rating scale that quantifies tremor in the head, face, voice, limbs and trunk. Items 6 (drawing an Archimedes spiral) and 7 (handwriting) of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 4, with 0 representing normal and 4 representing severely abnormal. The sum of the 6 items provides the TETRAS composite outcome score, which ranges from 0 - 24, with higher scores representing more severe ET.
Measured: Day-0 (Baseline) and Day-14 (follow-up)
Secondary outcomes (12)
Change in performance in a subset of The Essential Tremor Rating Assessment Scale- performance subscales (TETRAS-PS) between GyroGlove and placebo device at baseline in ET participants
TETARS-PS is a clinical rating scale that quantifies tremor in the head, face, voice, limbs and trunk. Items 6 (drawing an Archimedes spiral) and 7 (handwriting) of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 4, with 0 representing normal and 4 representing severely abnormal. The sum of the TETRAS-PS items, which ranges from 0 - 8, with higher scores representing more severe ET.
Measured: Day-0 (Baseline)
Change in Clinical Global Impression- Improvement scale (CGI-I) score between placebo and GyroGlove
The CGI-I is a 7-point Likert-type rating scale that a qualified medical personnel (ie, a clinician)will use to rate the severity of the participants' ability to function due to their ET. The responses to this scale range from 1 (Very much improved) to 7 (Very much worse).
Measured: Day-0 (Baseline)
Change in Patient Global Impression- Improvement scale (PGI-I) score between placebo and GyroGlove
The PGI-I is a 7-point Likert-type rating scale that participants use to rate the change in severity of their ability to function due to ET. The responses to this scale range from 1 (Very much better) to 7 (Very much worse).
Measured: Day-0 (Baseline)
Percentage of participants with Investigational devices-related adverse events as assessed by CTCAE v4.0
Safety outcome as measured by the incidence of investigational devices-related adverse events, event types from Day-0 (Baseline) to Day-14 (follow-up assessment)
Measured: Upto Day-14
Change in performance in a subset of The Essential Tremor Rating Assessment Scale- Activities of Daily Living (TETRAS ADL) subscales between baseline and follow-up assessment in ET participants
The Essential Tremor Rating Assessment Scale- Activities of Daily Living (TETRAS-ADL) subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as feeding with a spoon, drinking from a glass, pouring, using keys. Each item from the modified subscales ranges from 0 - 4, with 0 representing normal and 4 representing severely abnormal. The sum of the 4 items of TETRAS ADL subscale provide outcome score, which ranges from 0 - 16, with higher scores representing more severe ET.
Measured: Day-0 (Baseline) and Day-14 (follow-up)
Change in the Quality of Life in Essential Tremor Questionnaire (QUEST) score between baseline and follow-up assessment in ET participants
The Quality of Life in Essential Tremor Questionnaire (QUEST) was developed to specifically assess the impact of ET on health-related quality of life. The QUEST is a 30-item questionnaire comprising 5 subscales (physical, psychosocial, communication, hobbies/leisure, and work/finance) and a total score, plus 3 additional items relating to sexual function and satisfaction with tremor control and medication side effects. Each item is rated by frequency on a scale from 0 (never) to 4 (always), with higher scores indicating greater dissatisfaction or disability due to ET.
Measured: Day-0 (Baseline) and Day-14
Change in Patient Global Impression- Improvement scale (PGI-I) score between baseline and follow-up assessment in ET participants
The PGI-I is a 7-point Likert-type rating scale that participants use to rate the change in severity of their ability to function due to ET. The responses to this scale range from 1 (Very much better) to 7 (Very much worse).
Measured: Day-0 (Baseline) and Day-14 (follow-up)
Change in performance in a subset of The Essential Tremor Rating Assessment Scale- performance subscales (TETRAS-PS) between baseline and follow-up assessment in ET participants.
TETARS-PS is a clinical rating scale that quantifies tremor in the head, face, voice, limbs and trunk. Items 6 (drawing an Archimedes spiral) and 7 (handwriting) of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 4, with 0 representing normal and 4 representing severely abnormal. The sum of the TETRAS-PS items, which ranges from 0 - 8, with higher scores representing more severe ET.
Measured: Day-0 (Baseline) and Day-14 (follow-up)
Change in EQ-5D-5L score between baseline and follow-up assessment in ET participants
Health-related quality of life will be measured using the EuroQol Five Dimensions (EQ-5D). The EQ-5D-5L is a valid extension of the 3-level questionnaire. It can be defined as a standardized non-disease specific value-based instrument to describe and value health-related quality of life. The instrument consists of two components: the EQ-5D descriptive system and the EQ visual analogue scale (EQ-VAS).The first part consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories (no problems, slight problems, moderate problems, severe problems, and extreme problems). The EQ-VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health.
Measured: Day-0 (Baseline) and Day-14 (follow-up)
Change in performance in a subset of the Bain and Findley ADL tasks from Day-1 to Day-14
Bain \& Findley Activities of Daily Living (B\&F ADL) Scale is a patient rated scale. ADL tasks included in the study are: Use a spoon to drink soup ; Hold a cup of tea ; Pour milk from a bottle or carton ; Dial a telephone ; Pick up your change ; Insert an electric plug into a socket ; Unlock your front door with a key and Write a letter. Each task will be rated on a 4-point scale (1-4): 1 = Able to do the activity without difficulty ; 2 = Able to do the activity with a little effort ; 3 = Able to do the activity with a lot of effort ; 4 = Cannot do the activity by yourself.
Measured: Day-1 to Day-14
Change in Clinical Global Impression- Improvement scale (CGI-I) score between baseline and follow-up assessment in ET participants
The CGI-I is a 7-point Likert-type rating scale that a qualified medical personnel (ie, a clinician)will use to rate the severity of the participants' ability to function due to their ET. The responses to this scale range from 1 (Very much improved) to 7 (Very much worse).
Measured: Day-0 (Baseline) and Day-14 (follow-up)
Change in participants' experience of GyroGlove after 2-week intervention
Change in participants' experience of GyroGlove after 2-week home use will be assessed by utilising User Experience Questionnaire. Participants will complete User Experience Questionnaire form during follow-up visit.
Measured: Day-14 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study startJul 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- All study participants will interact with both investigational device and placebo in a pre-defined sequence.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GyroGear Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Walker, Principal investigator, North Tyneside General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958030
- Sponsor's protocol ID
- CLIN-0001
- Status last verified
- Mar 2025
- First submitted
- 5 Jul 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The study data collected during the study will be shared among study investigators in order to publish the study report at the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of GyroGlove in Stabilising Hand Tremors in Essential Tremor
- ClinicalTrials.gov ID
- NCT05958030
- Acronym / sponsor ID
- CLIN-0001
- Conditions
- Essential Tremor
- Keywords
- Essential Tremor, Activities of Daily Living
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- GyroGear LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Jul 2023 (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 is a multi-centre, single-blind, placebo-controlled trial with an open label follow up. After the baseline assessment, all participants will receive the GyroGlove for two weeks during the open label follow up part of the trial. All gloves will be retrieved and returned to GyroGear after closure of the study.
Detailed description
All participants will attend 2 in-clinic assessment sessions (Baseline (day 0), Follow-up (day 14)) after screening visit. The baseline session will last approximately 120 minutes whilst the 2-week assessment will last approximately 60-80 minutes. At baseline assessment, participants will perform protocol-specific activities with both investigational devices (i.e. GyroGlove and Placebo).
In addition to in-clinic assessments, participants will complete self-assessments at Day -3 prior baseline visit (i.e. Day 0,) and at Day 5 and 10 from baseline (i.e. Day 0), when they started using GyroGlove at home.
All participants will be blinded at the baseline (Day 0), as assessments will be performed with GyroGlove and a placebo device in a pre-defined sequence. Each participant will act as the control for him/herself and will be blinded to the interventions order.
The sequence of interventions in the study has been pre-defined, owing to the potential for longitudinal effects of wearing the device interfering with the accurate study outcome measurement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- All study participants will interact with both investigational device and placebo in a pre-defined sequence.
| Arm | Type | Receives |
|---|---|---|
| No Interventional | No intervention | –Participants will perform protocol-specific tasks with no device |
| Investigational Device Arm | Experimental | Device: GyroGloveGyroGlove |
| Placebo Arm | Placebo comparator | Device: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years of age or older
- Subject has been clinically diagnosed with ET
- Has either unilateral or bilateral tremor of the hand or predominantly hand as well as forearm
- Has a score of ≥ 2 in ADL activities 2, 3, 6 \& 8 of the TETRAS ADL subscale (TRG, Sep 2021)
- Tremor in at least one hand causing water spillage during drinking
Key exclusion criteria (18 listed)
- Other possible causes of tremor, including Parkinson's disease, drug-induced, enhanced physiological tremor
- Presence of tremor around the elbow and shoulder limiting participants to perform required test/procedure in the study
- Has implanted electrical medical device, e.g., pacemaker, defibrillator, or deep brain stimulator
- Clinically diagnosed alcohol use disorder or illicit substance use (exception medical cannabis)
- Change in medication for tremor within 1 month prior to study enrolment
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 |
|---|---|---|
| PlaceboThe placebo device consists of the same hardware as GyroGlove: aesthetically it looks the same, weight same and produces the same noise as GyroGlove. Participants will interact with Placebo on the day of baseline visit (i.e. Day 0). | Device | Placebo Arm |
| GyroGloveGyroGlove is a patented wearable device containing high-performance, miniaturised, gyroscopes designed for individuals diagnosed with essential tremor. Participants will interact with GyroGlove on the day of baseline visit (i.e. Day 0), 2-week Home use and on the day of follow-up visit (i.e Day 14). | Device | Investigational Device Arm |
Primary outcome
Change from Baseline to Week- 2 (follow-up assessment) on The Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score performance in ET participants
Time frame: Day-0 (Baseline) and Day-14 (follow-up)
The Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score is the sum of modified items 2, 3, 6 \& 8 of the TETRAS-ADL (Activities of Daily Living) subscale and modified items 6 - 7 of the TETRAS-PS (performance subscale). The TETRAS-ADL subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as feeding with a spoon, drinking from a glass, pouring, using keys etc. The TETARS-PS is a clinical rating scale that quantifies tremor in the head, face, voice, limbs and trunk. Items 6 (drawing an Archimedes spiral) and 7 (handwriting) of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 4, with 0 representing normal and 4 representing severely abnormal. The sum of the 6 items provides the TETRAS composite outcome score, which ranges from 0 - 24, with higher scores representing more severe ET.
12 secondary outcomes
Change in performance in a subset of The Essential Tremor Rating Assessment Scale- performance subscales (TETRAS-PS) between GyroGlove and placebo device at baseline in ET participants
Time frame: Day-0 (Baseline)
Change in Clinical Global Impression- Improvement scale (CGI-I) score between placebo and GyroGlove
Time frame: Day-0 (Baseline)
Change in Patient Global Impression- Improvement scale (PGI-I) score between placebo and GyroGlove
Time frame: Day-0 (Baseline)
Percentage of participants with Investigational devices-related adverse events as assessed by CTCAE v4.0
Time frame: Upto Day-14
Change in performance in a subset of The Essential Tremor Rating Assessment Scale- Activities of Daily Living (TETRAS ADL) subscales between baseline and follow-up assessment in ET participants
Time frame: Day-0 (Baseline) and Day-14 (follow-up)
Change in the Quality of Life in Essential Tremor Questionnaire (QUEST) score between baseline and follow-up assessment in ET participants
Time frame: Day-0 (Baseline) and Day-14
Change in Patient Global Impression- Improvement scale (PGI-I) score between baseline and follow-up assessment in ET participants
Time frame: Day-0 (Baseline) and Day-14 (follow-up)
Change in performance in a subset of The Essential Tremor Rating Assessment Scale- performance subscales (TETRAS-PS) between baseline and follow-up assessment in ET participants.
Time frame: Day-0 (Baseline) and Day-14 (follow-up)
Change in EQ-5D-5L score between baseline and follow-up assessment in ET participants
Time frame: Day-0 (Baseline) and Day-14 (follow-up)
Change in performance in a subset of the Bain and Findley ADL tasks from Day-1 to Day-14
Time frame: Day-1 to Day-14
Change in Clinical Global Impression- Improvement scale (CGI-I) score between baseline and follow-up assessment in ET participants
Time frame: Day-0 (Baseline) and Day-14 (follow-up)
Change in participants' experience of GyroGlove after 2-week intervention
Time frame: Day-14 (follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No. The study data collected during the study will be shared among study investigators in order to publish the study report at the end of the study.
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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.
Richard Walker principal investigator
North Tyneside General Hospital
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GyroGlove in people with Essential Tremor, run by GyroGear Ltd at 7 sites in 2 countries.
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 11 inclusion and 18 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: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faii Ong (+44 2045773038, clinical@gyrogear.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week- 2 (follow-up assessment) on The Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score performance in ET participants (time frame: Day-0 (Baseline) and Day-14 (follow-up)). 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 14 Mar 2025.