Essential TremorNCT02629614
Cala ONE Device for Essential Tremor
A study testing Cala ONE Device in people with Essential Tremor, run by Cala Health, Inc. at 4 sites in United States.
Trial summary
This study evaluates the safety and effectiveness of the Cala ONE device to aid in the symptomatic relief of hand tremors in adult essential tremor subjects. This study is a prospective, randomized, double-blinded, sham-controlled study. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Cala ONE Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 22 years or older
- A diagnosis of essential tremor as confirmed from clinical history and examination by a movement disorder neurologist
- Signed informed consent
- At least one hand exhibiting kinetic tremor ≥ 2 as assessed by the TETRAS Archimedes spiral task completed during the baseline evaluation, as assessed by the Investigator in-person.
- Score of 3 or above in any one of the items of the Bain \& Findley ADL Scale
Who cannot join
- Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
- Previous thalamotomy procedure, including Stereotactic Thalamotomy, Gamma Knife Radiosurgical Thalamotomy, and focused ultrasound, for the treatment of tremor
- Suspected or diagnosed epilepsy or other seizure disorder
- Pregnant
- Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
- Peripheral neuropathy affecting the tested upper extremity
Show all 16Show fewer
- Alcoholism (score of 4 or higher on DSM-5)
- Other possible causes of tremor, including Parkinson's disease, drug-induced, enhanced physiological tremor, dystonia
- Other neurodegenerative disease like Parkinson-plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and cortical basal ganglionic degeneration
- Changes in medication for tremor within 1 month prior to study enrollment
- Change in antidepressant medication within 3 months prior to study enrollment
- Botulinum Toxin injection for hand tremor within 6 months prior to study enrollment
- Current participation in any other interventional research study
- Previous participation in any other Cala Health interventional research study
- Alcohol or caffeine consumption within 12 hours of study enrollment
- Subjects already taking medications for their essential tremor will remain on their medications during the study with no changes in medication type or dosage levels.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kansas University Medical Center
Kansas City, Kansas, 66103
UCSF
San Francisco, California, 94121
Swedish Medical Center Seattle
Seattle, Washington, 98122
The Parkinson's Institute
Sunnyvale, California, 94085
About this study
Official title: Multicenter Study of Safety and Effectiveness of Cala ONE Device for Essential Tremor
This study evaluates the safety and effectiveness of the Cala ONE device to aid in the symptomatic relief of hand tremors in adult essential tremor subjects. This study is a prospective, randomized, double-blinded, sham-controlled study.
- Conditions
- Essential Tremor
- Being tested
- Cala ONE Device
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cala ONE DeviceDevice
The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
| Study group | Role | What they receive |
|---|---|---|
| TAPS Stimulation | Experimental | Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Receives: Device: Cala ONE Device |
| Sham Stimulation | Sham comparator | 0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Receives: Device: Cala ONE Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TETRAS Spiral Rating After Stimulation
The primary effectiveness variable is the change in tremor severity immediately after the stimulation session compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters).
The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Measured: Immediately before and after 40 minute stimulation session
Secondary outcomes (2)
Change in TETRAS Spiral Rating During Stimulation
An additional analysis variable is the change in tremor severity during the stimulation session (30 minutes into stimulation session) compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters).
The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Measured: Immediately before and 30 minutes into stimulation session
Self-report Improvement
The percentage of subjects in the treatment group indicating improvement on the CGI-I Scale will be compared to the sham group. The Clinical Global Impression - Improvement (GGI-I) scale evaluates a clinician's rating of tremor improvement noted in the subject, as a result of the treatment. The scale ranges from 1 (very much improved) to 7 (very much worse).
Measured: Immediately before and after 40 minute stimulation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startApr 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cala Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin, MD, Study chair, Clinical Advisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629614
- Sponsor's protocol ID
- ET-03
- Status last verified
- Jun 2023
- First submitted
- 8 Dec 2015
- Last updated
- 18 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will be published, but no PHI will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Safety and Effectiveness of Cala ONE Device for Essential Tremor
- ClinicalTrials.gov ID
- NCT02629614
- Acronym / sponsor ID
- ET-03
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Cala Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 14 Dec 2015 (estimated)
- Results
- Posted 18 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety and effectiveness of the Cala ONE device to aid in the symptomatic relief of hand tremors in adult essential tremor subjects. This study is a prospective, randomized, double-blinded, sham-controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAPS Stimulation | Experimental | Device: Cala ONE DeviceTemporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. |
| Sham Stimulation | Sham comparator | Device: Cala ONE Device0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 22 years or older
- A diagnosis of essential tremor as confirmed from clinical history and examination by a movement disorder neurologist
- Signed informed consent
- At least one hand exhibiting kinetic tremor ≥ 2 as assessed by the TETRAS Archimedes spiral task completed during the baseline evaluation, as assessed by the Investigator in-person.
- Score of 3 or above in any one of the items of the Bain \& Findley ADL Scale
Key exclusion criteria (16 listed)
- Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
- Previous thalamotomy procedure, including Stereotactic Thalamotomy, Gamma Knife Radiosurgical Thalamotomy, and focused ultrasound, for the treatment of tremor
- Suspected or diagnosed epilepsy or other seizure disorder
- Pregnant
- Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
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 |
|---|---|---|
| Cala ONE DeviceThe Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes. | Device | Sham Stimulation, TAPS Stimulation |
Primary outcome
Change in TETRAS Spiral Rating After Stimulation
Time frame: Immediately before and after 40 minute stimulation session
The primary effectiveness variable is the change in tremor severity immediately after the stimulation session compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
2 secondary outcomes
Change in TETRAS Spiral Rating During Stimulation
Time frame: Immediately before and 30 minutes into stimulation session
Self-report Improvement
Time frame: Immediately before and after 40 minute stimulation session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data will be published, but no PHI will be made available.
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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.
Lin, MD study chair
Clinical Advisor
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cala ONE Device in people with Essential Tremor, run by Cala Health, Inc. at 4 sites 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 5 inclusion and 16 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: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
Yes. Results are posted in the registry (first posted 18 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Spiral Rating After Stimulation (time frame: Immediately before and after 40 minute stimulation session). 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 Jul 2023.