Essential TremorNCT05480215
Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands
A study testing Cala Device in people with Essential Tremor and Parkinson Disease, run by Cala Health, Inc. at 1 site in United States.
Trial summary
Demonstrate safety and effectiveness of symptomatic action tremor relief in the treated hand following stimulation with the Cala Trio System using the Trio+ bands as compared to the Trio bands in adults with Essential Tremor (ET) and/or Parkinson's Disease (PD) over 2 weeks. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Essential Tremor, Parkinson Disease
- What is being tested?
- Cala Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2021to 16 Dec 2021
- 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 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
- Willing to comply with study protocol requirements
- For subjects with Essential Tremor:
- A diagnosis of essential tremor
- A tremor severity score of 2 or above in the dominant hand/arm as measured by one of the TETRAS upper limb postural tremor items
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- No significant alcohol intake within 8 hours prior to study visits
- For subjects with Parkinson's Disease:
- Dominant hand/arm exhibiting postural tremor ≥ 2 (while in the off state) as assessed by the MDS-UPDRS postural tremor score
- Stable dose of Parkinson's disease medications, if applicable, for 30 days prior to study entry
Who cannot join
- Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
- Suspected or diagnosed epilepsy or other seizure disorder
- Any skin condition at the stimulation site that in the investigator's opinion should preclude participation in this study
- Diagnosed with peripheral neuropathy affecting the tested upper extremity
- Presence of any other neurodegenerative disease other than essential tremor or Parkinson's Disease
- Subjects unable to communicate with the investigator and staff
Show all 10Show fewer
- Any health condition or concomitant medication that in the investigator's opinion should preclude participation in this study
- Pregnancy or anticipated pregnancy during the course of the study
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study for Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands
Demonstrate safety and effectiveness of symptomatic action tremor relief in the treated hand following stimulation with the Cala Trio System using the Trio+ bands as compared to the Trio bands in adults with Essential Tremor (ET) and/or Parkinson's Disease (PD) over 2 weeks.
Read the detailed description
20 patients with (13 with ET and 7 with PD) with at least mild postural tremor were enrolled in a prospective, single-center, two-arm, crossover study that took place over the course of four weeks. TAPS devices were shipped to patients to run the study remotely. In the first arm of the study, subjects received TAPS treatment using the original. Cala Trio band for two weeks. Followed by a wash-out period (> 24 hours), subjects entered the second arm and received TAPS using the Trio+ band for an additional two weeks. Unsupervised motion assessments were captured at home, and at the beginning and end of the four weeks by telemedicine.
- Conditions
- Essential Tremor, Parkinson Disease
- Being tested
- Cala Device
- Medical subject headings
- Essential Tremor, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cala DeviceDevice
transcutaneous afferent patterned stimulation (TAPS)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: TAPS delivered by Cala device with Trio band | Experimental | Two 40-minute TAPS sessions daily for 14 days Receives: Device: Cala Device |
| Experimental: TAPS delivered by Cala device with Trio+ band | Experimental | Two 40-minute TAPS sessions daily for 14 days Receives: Device: Cala Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor power changes from pre-stimulation to post-stimulation
Tremor improvement was measured by Tremor Power Improvement Ratio (TPIR) using kinematic data collected by the device. The TPIR was calculated as pre-stimulation power divided by post-stimulation power, which was computed from device-collected accelerometer data
Measured: baseline, pre-intervention and immediately after the intervention
Secondary outcomes (3)
Change in TETRAS from pre-stimulation to post- stimulation within each visit
For subjects with Essential Tremor only: Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) subset score, relevant to the stimulated upper limb, change from pre-stimulation to post- stimulation within each visit
Measured: baseline, pre-intervention and immediately after the intervention
Change in UPDRS Part III from pre-stimulation to post- stimulation within each visit
For subjects with Parkinson's Disease only: Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS) subset score, change from pre- stimulation to post-stimulation within each visit
Measured: baseline, pre-intervention and immediately after the intervention
Change in BF-ADL
Change in the Bain \& Findley activities of daily living (BF-ADL) score from pre- to post-stimulation at each of the two study visits associated with the Trio and Trio+ bands (four study visits total)
Measured: baseline, pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start7 Oct 2021
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT05480215
- Sponsor's protocol ID
- ET-22
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- 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 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands
- ClinicalTrials.gov ID
- NCT05480215
- Acronym / sponsor ID
- ET-22
- Conditions
- Essential Tremor, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cala Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 29 Jul 2022 (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.
Demonstrate safety and effectiveness of symptomatic action tremor relief in the treated hand following stimulation with the Cala Trio System using the Trio+ bands as compared to the Trio bands in adults with Essential Tremor (ET) and/or Parkinson's Disease (PD) over 2 weeks.
Detailed description
20 patients with (13 with ET and 7 with PD) with at least mild postural tremor were enrolled in a prospective, single-center, two-arm, crossover study that took place over the course of four weeks. TAPS devices were shipped to patients to run the study remotely. In the first arm of the study, subjects received TAPS treatment using the original. Cala Trio band for two weeks. Followed by a wash-out period (> 24 hours), subjects entered the second arm and received TAPS using the Trio+ band for an additional two weeks. Unsupervised motion assessments were captured at home, and at the beginning and end of the four weeks by telemedicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: TAPS delivered by Cala device with Trio band | Experimental | Device: Cala DeviceTwo 40-minute TAPS sessions daily for 14 days |
| Experimental: TAPS delivered by Cala device with Trio+ band | Experimental | Device: Cala DeviceTwo 40-minute TAPS sessions daily for 14 days |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must be ≥22 years of age
- Competent and willing to provide written, informed consent to participate in the study
- Willing to comply with study protocol requirements
- A diagnosis of essential tremor
- A tremor severity score of 2 or above in the dominant hand/arm as measured by one of the TETRAS upper limb postural tremor items
Key exclusion criteria (10 listed)
- Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
- Suspected or diagnosed epilepsy or other seizure disorder
- Any skin condition at the stimulation site that in the investigator's opinion should preclude participation in this study
- Diagnosed with peripheral neuropathy affecting the tested upper extremity
- Presence of any other neurodegenerative disease other than essential tremor or Parkinson's Disease
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 Devicetranscutaneous afferent patterned stimulation (TAPS) | Device | Experimental: TAPS delivered by Cala device with Trio band, Experimental: TAPS delivered by Cala device with Trio+ band |
Primary outcome
Tremor power changes from pre-stimulation to post-stimulation
Time frame: baseline, pre-intervention and immediately after the intervention
Tremor improvement was measured by Tremor Power Improvement Ratio (TPIR) using kinematic data collected by the device. The TPIR was calculated as pre-stimulation power divided by post-stimulation power, which was computed from device-collected accelerometer data
3 secondary outcomes
Change in TETRAS from pre-stimulation to post- stimulation within each visit
Time frame: baseline, pre-intervention and immediately after the intervention
Change in UPDRS Part III from pre-stimulation to post- stimulation within each visit
Time frame: baseline, pre-intervention and immediately after the intervention
Change in BF-ADL
Time frame: baseline, pre-intervention and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cala Device in people with Essential Tremor and Parkinson Disease, run by Cala Health, Inc. 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 10 inclusion and 10 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 29 Jul 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tremor power changes from pre-stimulation to post-stimulation (time frame: baseline, pre-intervention and immediately after the intervention). 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 29 Jul 2022.