Essential TremorNCT05540626
RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor
A study testing Cala Trio in people with Essential Tremor, run by Cala Health, Inc. at 1 site in United States.
Trial summary
The study objective is to evaluate hand tremor relief in the treated hand following stimulation with the Cala Trio Device in adults with essential tremor, and healthcare resource utilization and total healthcare costs over a 12-month period. 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 Trio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2021to 1 Mar 2024
- 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
- Age ≥22years
- Aetna commercial fully insured OR Medicare Advantage population (inclusion of Medicare is contingent upon additional internal approvals)
- Two ICD claims for ET, at least seven days apart, in the last three years OR one ICD claim for ET followed by at least one dispensed pharmaceutical treatment for ET
- Contraindication to standard pharmacological therapy (Asthma, COPD, 1stor 2nddegree heart block) OR indicator of poor pharmacological acceptability as evidenced by drug switching behaviors OR indicator of drug resistance as evidenced by the use of third-line drug therapies including Clozapine, Mirtazapine, Gabapentin, Topiramate, Clonazepam or Alprazolam
- Willing and able to provide informed consent to participate in the study
- Willing and able to follow study protocol requirements
- Patients with PCP or neurologist provider encounter in past 18months
Who cannot join
- ICD-10 evidence of a pacemaker or defibrillator or a procedure code indicating pacemaker implantation, electrode renewal or calibration
- ICD-10 evidence of a deep brain stimulator or a procedure code indicating DBS implantation
- CPT/HCPCS evidence of thalamotomy, gamma-knife radio surgical thalamotomy
- NDC and CPT evidence of botulinum toxin the last 6 months as therapeutic injection in the upper limb
- Pregnant during the enrollment period
- Evidence of Parkinson's Disease
Show all 11Show fewer
- Evidence of epilepsy
- Formal diagnosis of hypothyroidism and treatment
- Formal diagnosis of hyperthyroidism without evidence of treatment
- Formal diagnosis of dementia
- Evidence of Treatment with thyroid hormone supplements (2 Rx claims 28 or more days apart) or evidence of hyperthyroidism (2+ claims, 28 days or more apart)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real World Evidence Study Utilizing the Cala Trio Device in Patients With Essential Tremor
The study objective is to evaluate hand tremor relief in the treated hand following stimulation with the Cala Trio Device in adults with essential tremor, and healthcare resource utilization and total healthcare costs over a 12-month period.
Read the detailed description
This is a prospective, randomized, dual arm, pragmatic trial in a real-world setting to evaluate the effectiveness and health economics outcomes of the Cala Trio device in reducing hand tremor and improving quality of life as measured by the Bain and Findley Activities of Daily Living (ADL) score relevant to the stimulated upper limb. Healthcare resources utilization and total all-cause healthcare will also be evaluated. The study will recruit approximately 300 patients: 150 in the intervention arm (Cala Trio device)and 150 patients in the standard of care (SOC) arm. Subjects will be randomized to either the intervention arm or the standard of care arm (1:1).Subjects in the SOC arm will be asked to measure their tremor severity by doing daily postural holds with the Cala Trio device without actual stimulation. Subjects in the intervention arm will wear the device at home for a period of 12 months, during which they will deliver 40 min stimulation sessions, which can be started and stopped on demand. After the first month, the subjects who were randomized to the SOC arm will cross over to the intervention arm.
- Conditions
- Essential Tremor
- Being tested
- Cala Trio
- 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 TrioDevice
transcutaneous afferent patterned stimulation (TAPS)
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Arm | No intervention | Baseline tremor power without stimulation (SOC arm) over the first month of the study. Subjects in the SOC arm will be asked to measure their tremor severity by doing daily postural holds with the Cala Trio device without actual stimulation. |
| Intervention with the Cala Trio device (CTD) arm | Experimental | Tremor power after stimulation with Cala Trio. Subjects in the intervention arm will wear the device at home for a period of 12 months, during which they will deliver 40 min stimulation sessions, which can be started and stopped on demand. Receives: Device: Cala Trio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tremor power
Difference in tremor power after stimulation with Cala Trio (treated arm) and baseline tremor power without stimulation (SOC arm) over the first month of the study.
Prior to and immediately after each of the first 40 stimulation sessions and every 7th session thereafter, the Cala Trio will direct the patient to perform postural hold tremor tasks to measure tremor power pre and post stimulation. The SOC arm will perform a tremor measurement only, without any stimulation sessions, for 1 month.
Measured: 1 Month
Secondary outcomes (2)
Bain & Findley Activities of Daily Living (BF-ADL) scale subset score
BF-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. Improvements in BF-ADL scores will be measured from baseline over the 12 months study duration.
Measured: 12 Months
Tremor power improvement ratio (TPIR)
TPIR is defined as the ratio of pre- to post-stimulation tremor power. Per-patient median TPIR over first, second, third, and fourth quarters of the study (i.e., months 1 - 3, 4 - 6, etc.) will be assessed.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start8 Apr 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cala Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CVS Healthspire Life Sciences Solutions
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540626
- Sponsor's protocol ID
- Aetna RWE
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2022
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Brillman S, Khemani P, Isaacson SH, Pahwa R, Deshpande R, Zraick V, Rajagopal A, Khosla D, Rosenbluth KH. Non-Invasive Transcutaneous Afferent Patterned Stimulation Therapy Offers Action Tremor Relief in Parkinson's Disease. Tremor Other Hyperkinet Mov (N Y). 2023 Aug 23;13:25. doi: 10.5334/tohm.762. eCollection 2023.
PubMed 37637850
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evidence Study Utilizing the Cala Trio Device in Patients With Essential Tremor
- ClinicalTrials.gov ID
- NCT05540626
- Acronym / sponsor ID
- Aetna RWE
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Cala Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- CVS Healthspire Life Sciences Solutions
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 14 Sep 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.
The study objective is to evaluate hand tremor relief in the treated hand following stimulation with the Cala Trio Device in adults with essential tremor, and healthcare resource utilization and total healthcare costs over a 12-month period.
Detailed description
This is a prospective, randomized, dual arm, pragmatic trial in a real-world setting to evaluate the effectiveness and health economics outcomes of the Cala Trio device in reducing hand tremor and improving quality of life as measured by the Bain and Findley Activities of Daily Living (ADL) score relevant to the stimulated upper limb. Healthcare resources utilization and total all-cause healthcare will also be evaluated. The study will recruit approximately 300 patients: 150 in the intervention arm (Cala Trio device)and 150 patients in the standard of care (SOC) arm. Subjects will be randomized to either the intervention arm or the standard of care arm (1:1).Subjects in the SOC arm will be asked to measure their tremor severity by doing daily postural holds with the Cala Trio device without actual stimulation. Subjects in the intervention arm will wear the device at home for a period of 12 months, during which they will deliver 40 min stimulation sessions, which can be started and stopped on demand. After the first month, the subjects who were randomized to the SOC arm will cross over to the intervention arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Arm | No intervention | –Baseline tremor power without stimulation (SOC arm) over the first month of the study. Subjects in the SOC arm will be asked to measure their tremor severity by doing daily postural holds with the Cala Trio device without actual stimulation. |
| Intervention with the Cala Trio device (CTD) arm | Experimental | Device: Cala TrioTremor power after stimulation with Cala Trio. Subjects in the intervention arm will wear the device at home for a period of 12 months, during which they will deliver 40 min stimulation sessions, which can be started and stopped on demand. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥22years
- Aetna commercial fully insured OR Medicare Advantage population (inclusion of Medicare is contingent upon additional internal approvals)
- Two ICD claims for ET, at least seven days apart, in the last three years OR one ICD claim for ET followed by at least one dispensed pharmaceutical treatment for ET
- Contraindication to standard pharmacological therapy (Asthma, COPD, 1stor 2nddegree heart block) OR indicator of poor pharmacological acceptability as evidenced by drug switching behaviors OR indicator of drug resistance as evidenced by the use of third-line drug therapies including Clozapine, Mirtazapine, Gabapentin, Topiramate, Clonazepam or Alprazolam
- Willing and able to provide informed consent to participate in the study
Key exclusion criteria (11 listed)
- ICD-10 evidence of a pacemaker or defibrillator or a procedure code indicating pacemaker implantation, electrode renewal or calibration
- ICD-10 evidence of a deep brain stimulator or a procedure code indicating DBS implantation
- CPT/HCPCS evidence of thalamotomy, gamma-knife radio surgical thalamotomy
- NDC and CPT evidence of botulinum toxin the last 6 months as therapeutic injection in the upper limb
- Pregnant during the enrollment period
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 Triotranscutaneous afferent patterned stimulation (TAPS) | Device | Intervention with the Cala Trio device (CTD) arm |
Primary outcome
Change in tremor power
Time frame: 1 Month
Difference in tremor power after stimulation with Cala Trio (treated arm) and baseline tremor power without stimulation (SOC arm) over the first month of the study. Prior to and immediately after each of the first 40 stimulation sessions and every 7th session thereafter, the Cala Trio will direct the patient to perform postural hold tremor tasks to measure tremor power pre and post stimulation. The SOC arm will perform a tremor measurement only, without any stimulation sessions, for 1 month.
2 secondary outcomes
Bain & Findley Activities of Daily Living (BF-ADL) scale subset score
Time frame: 12 Months
Tremor power improvement ratio (TPIR)
Time frame: 12 Months
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 21 Oct 2026.
- Derived from this study: PubMed 37637850Brillman S, Khemani P, Isaacson SH, Pahwa R, Deshpande R, Zraick V, Rajagopal A, Khosla D, Rosenbluth KH. Non-Invasive Transcutaneous Afferent Patterned Stimulation Therapy Offers Action Tremor Relief in Parkinson's Disease. Tremor Other Hyperkinet Mov (N Y). 2023 Aug 23;13:25. doi: 10.5334/tohm.762. eCollection 2023.
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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 Trio in people with Essential Tremor, 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 7 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: finished, as of the sponsor's last update on 21 Oct 2026. 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?
Change in tremor power (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05540626, which also lists 1 linked publication.
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 21 Oct 2026.