Essential TremorPROSPECTNCT03597100
Prospective Study for Symptomatic Relief of ET With Cala Therapy
A study testing Cala TWO in people with Essential Tremor, run by Cala Health, Inc. at 32 sites in United States.
Trial summary
Prospective, multi-center, single-arm, non-significant risk study designed to evaluate the Cala TWO device. Subjects will be screened for eligibility and fitted with a Cala TWO device. 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 TWO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 32 sitesUnited States
- Study dates
- 14 Dec 2018to 29 May 2019
- 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
- Must be ≥22 years of age
- Competent and willing to provide written, informed consent to participate in the study
- A diagnosis of essential tremor as confirmed from clinical history and examination by a movement disorder neurologist
- A tremor severity score of 2 or above in the dominant hand/arm as measured by any one of the TETRAS upper limb items and a minimum subset score of 6 across all upper limb items
- Significant disability due to essential tremor (Bain \& Findley score of 3 or above in any one of the upper limb items and a minimum subset score of 8 across all upper limb items)
- Stable dose of tremor medications, if applicable, for 30 days prior to study entry
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- Stable dose of antidepressant medications, if applicable, for 90 days prior to study entry
- Willing to comply with study protocol requirements including:
- remaining on a stable dosage of tremor and antidepressant medications, if applicable, during the duration of the study
- no significant alcohol or caffeine consumption within 8 hours prior to study visits
- no usage of the Cala TWO device within 8 hours prior to study visits
Who cannot join
- Moderate to severe ethanol dependence as defined by the criteria outlined in the DSM-5 (score of 4 or higher)
- Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator, or implanted metal in the wrist to be stimulated
- 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
- Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
- Peripheral neuropathy affecting the tested upper extremity
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- Presence of any other neurodegenerative disease like Parkinson-plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
- Anyone suspected to have the diagnosis of idiopathic Parkinson's disease (PD). This includes excluding anyone with the presence of parkinsonian features including bradykinesia rigidity, or postural instability. Subjects who exhibit only mild resting tremor but no other symptoms or signs of PD may be included.
- Botulinum toxin injection for hand tremor within 6 months prior to study enrollment
- Are participating or have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor
- Significant alcohol or caffeine consumption within 8 hours prior to study enrollment, which may confound the results of the study, where significant caffeine is considered more than 95 mg (equivalent to a cup of coffee), and significant alcohol is considered more than 14 g (equivalent to 5 oz of wine, 12 oz of beer, or 1.5 oz of distilled spirits).
- Subjects unable to communicate with the investigator and staff
- Any health condition that in the investigator's opinion should preclude participation in this study
- Pregnancy or anticipated pregnancy during the course of the study
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Augusta University
Augusta, Georgia, 30912
Swedish
Bellevue, Washington, 98004
Parkinson's Center
Boca Raton, Florida, 33486
Deaconess Medical Center
Boston, Massachusetts, 02215
Rush University Medical Center
Chicago, Illinois, 60612
River Hills Neuroscience
Cincinnati, Ohio, 45255
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Southwestern
Dallas, Texas, 75390
Rocky Mountain Movement Disorders Center
Denver, Colorado, 80113
Duke University
Durham, North Carolina, 27710
Medstar Gerogetown Health Institute
Georgetown, District of Columbia, 20007
Texas Movement Disorder Specialist
Georgetown, Texas, 78628
Advanced Neurology Specialists
Great Falls, Montana, 95405
Houston Methodist
Houston, Texas, 77030
Kansas University Medical Center
Kansas City, Kansas, 66160
EvergreenHealth Medical Center
Kirkland, Washington, 98034
Kaiser Mid-Atlantic Group
Largo, Maryland, 20774
Parkinson's Disease and Movement Disorders Center of Long Island
Long Island City, New York, 10017
USC
Los Angeles, California, 90033
Parkinson's Institute and Clinical Center
Mountain View, California, 94040
Hospital for Special Care
New Britain, Connecticut, 06053
Mount Sinai & Beth Isreal
New York, New York, 10003
University Of Pennsylvania Medicine
Philadelphia, Pennsylvania, 19104
Jefferson University
Philadelphia, Pennsylvania, 19144
Barrow Neurological Institute (Dignity Health)
Phoenix, Arizona, 85013
Wake Forest
Raleigh, North Carolina, 27157
Mayo Clinic
Rochester, Minnesota, 55902
Central Texas Neurology Consultants
Round Rock, Texas, 78681
University of California San Francisco
San Francisco, California, 94143
Pacific Neuroscience Institute
Santa Monica, California, 90404
USF
Tampa, Florida, 33612
Henry Ford Health System
West Bloomfield, Michigan, 48322
About this study
Official title: Prospective Study for Symptomatic Relief of Essential Tremor With Cala Therapy
Prospective, multi-center, single-arm, non-significant risk study designed to evaluate the Cala TWO device. Subjects will be screened for eligibility and fitted with a Cala TWO device. Subjects will wear the device at home for a period of 3 months, during which they will be asked to stimulate their dominant hand twice a day. The stimulation amplitude will be based on each subject's stimulation threshold. Subjects will have in clinic assessments at enrollment, month 1 and 3.
- Conditions
- Essential Tremor
- Being tested
- Cala TWO
- 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 TWODevice
Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves
| Study group | Role | What they receive |
|---|---|---|
| Cala TWO | Experimental | Two 40-minute stimulation sessions daily, separated by at least two hours Receives: Device: Cala TWO |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRG (Tremor Research Group) Essential Tremor Rating Assessment Scale (TETRAS) Subset Score
Tremor Research Group (TRG) Essential Tremor Rating Assessment Scale (TETRAS) subset score: TETRAS subset score relevant to the stimulated upper limb. The subset score is the sum of 6 rated tasks. Each task is rated 0 to 4, where a higher score indicates more severe tremor. Minimum subset score = 0; Maximum subset score = 24.
Measured: Baseline to 3-months
Bain & Findley Activities of Daily Living (ADL) Scale Subset Score
Bain \& Findley ADL subset score relevant to the stimulated upper limb. The subset score is the sum of 8 rated tasks. Each task is rated 1 to 4, where a higher score indicates more severe tremor. Minimum subset score = 8; Maximum subset score = 32.
Measured: Baseline to 3-months
Secondary outcomes (1)
Kinematic Measurements, as Collected With the Device During Postural Holds, Change From Pre-stimulation to Post-stimulation Across Sessions
Subjects will be prompted to perform a postural hold task before and after each stimulation session. During this task, the device will record kinematic data using on-board motion sensors to objectively assess if there are any changes in tremor level. The change in each patient's pre- and post-stimulation tremor power was defined as the median change over all valid stimulation sessions. Sample mean and standard deviations were computed using the median change value from all patients.
Measured: Average change in tremor power over 3-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start14 Dec 2018
- Primary completion29 May 2019
- Study completion29 May 2019
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cala Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597100
- Sponsor's protocol ID
- ET-14
- Acronym
- PROSPECT
- Status last verified
- Oct 2023
- First submitted
- 27 Jun 2018
- Last updated
- 12 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for Symptomatic Relief of Essential Tremor With Cala Therapy
- ClinicalTrials.gov ID
- NCT03597100
- Acronym / sponsor ID
- PROSPECT / ET-14
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Cala Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Posted 12 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center, single-arm, non-significant risk study designed to evaluate the Cala TWO device. Subjects will be screened for eligibility and fitted with a Cala TWO device. Subjects will wear the device at home for a period of 3 months, during which they will be asked to stimulate their dominant hand twice a day. The stimulation amplitude will be based on each subject's stimulation threshold. Subjects will have in clinic assessments at enrollment, month 1 and 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cala TWO | Experimental | Device: Cala TWOTwo 40-minute stimulation sessions daily, separated by at least two hours |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Must be ≥22 years of age
- Competent and willing to provide written, informed consent to participate in the study
- A diagnosis of essential tremor as confirmed from clinical history and examination by a movement disorder neurologist
- A tremor severity score of 2 or above in the dominant hand/arm as measured by any one of the TETRAS upper limb items and a minimum subset score of 6 across all upper limb items
- Significant disability due to essential tremor (Bain \& Findley score of 3 or above in any one of the upper limb items and a minimum subset score of 8 across all upper limb items)
Key exclusion criteria (14 listed)
- Moderate to severe ethanol dependence as defined by the criteria outlined in the DSM-5 (score of 4 or higher)
- Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator, or implanted metal in the wrist to be stimulated
- 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
- 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 TWOWrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves | Device | Cala TWO |
Primary outcome
TRG (Tremor Research Group) Essential Tremor Rating Assessment Scale (TETRAS) Subset Score
Time frame: Baseline to 3-months
Tremor Research Group (TRG) Essential Tremor Rating Assessment Scale (TETRAS) subset score: TETRAS subset score relevant to the stimulated upper limb. The subset score is the sum of 6 rated tasks. Each task is rated 0 to 4, where a higher score indicates more severe tremor. Minimum subset score = 0; Maximum subset score = 24.
Bain & Findley Activities of Daily Living (ADL) Scale Subset Score
Time frame: Baseline to 3-months
Bain \& Findley ADL subset score relevant to the stimulated upper limb. The subset score is the sum of 8 rated tasks. Each task is rated 1 to 4, where a higher score indicates more severe tremor. Minimum subset score = 8; Maximum subset score = 32.
1 secondary outcome
Kinematic Measurements, as Collected With the Device During Postural Holds, Change From Pre-stimulation to Post-stimulation Across Sessions
Time frame: Average change in tremor power over 3-month study period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cala TWO in people with Essential Tremor, run by Cala Health, Inc. at 32 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 11 inclusion and 14 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 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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. 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 12 Oct 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?
TRG (Tremor Research Group) Essential Tremor Rating Assessment Scale (TETRAS) Subset Score (time frame: Baseline to 3-months). The study lists 2 primary outcomes in all. 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 12 Oct 2023.