Cala Trio Device for Essential Tremor

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cala Health, Inc.

Must not be taking: Thyroid supplements, Botulinum toxin

Disqualifiers: Pacemaker, Deep brain stimulator, Parkinson's, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively the Cala Trio device reduces hand tremors in individuals with essential tremor, a condition that causes uncontrollable shaking. The study compares participants using the device with those not receiving additional treatment to assess its true effects. Participants will also provide insights into how using the device impacts overall healthcare costs over a year. Suitable candidates typically have essential tremor not well-managed by medication and may have tried various drugs without much success. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it seems to focus on patients who have issues with standard medications, so you might not need to stop them.

What prior data suggests that the Cala Trio Device is safe for essential tremor?

Research has shown that the Cala Trio device is generally safe for most people. The FDA has approved this wearable device to help reduce hand tremors in adults with essential tremor. Studies have found that it can temporarily ease these tremors.

However, some important safety notes exist. People with certain implanted electrical medical devices, like pacemakers, should not use the Cala Trio to avoid possible interference.

Overall, the Cala Trio is well-tolerated, with no widespread reports of serious side effects. For those considering joining a trial, this device has demonstrated effectiveness in reducing hand tremors without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cala Trio device because it offers a non-invasive, drug-free approach to managing essential tremor. Unlike medications like beta-blockers or anti-seizure drugs, which can have various side effects, the Cala Trio uses targeted electrical stimulation to reduce tremor symptoms. This wearable device allows users to control treatment sessions on demand, providing a personalized and flexible alternative to traditional therapies.

What evidence suggests that the Cala Trio device is effective for essential tremor?

Research shows that the Cala Trio device helps reduce shaking in people with essential tremor. Studies have found that it can decrease tremor strength by 64% to 76%, making hand shaking much less noticeable. In this trial, participants in the intervention arm will use the Cala Trio device for 40-minute stimulation sessions. The device sends small electrical signals to certain nerves, helping control the tremors. Users have regularly used the device without it becoming less effective over time. Overall, evidence suggests that the Cala Trio is a promising option for managing essential tremors. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 22 with essential tremor who can't use standard drugs due to conditions like asthma or heart block, or haven't responded well to other treatments. They must have seen a doctor recently and be part of Aetna's insured or Medicare Advantage groups. People with Parkinson's, certain thyroid disorders, brain surgeries, epilepsy, dementia, or those pregnant can't join.

Inclusion Criteria

I have had at least two insurance claims for essential tremor, or one claim followed by treatment.

I cannot take standard medications due to my asthma, COPD, or heart issues, or my medications do not work well for me.

Willing and able to follow study protocol requirements

Exclusion Criteria

You have been diagnosed with dementia.

I have been treated for thyroid issues with medication or have had hyperthyroidism.

I have been diagnosed with Parkinson's Disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline tremor power without stimulation is measured in the SOC arm over the first month

1 month

Daily postural holds

Treatment

Participants in the intervention arm use the Cala Trio device for 40 min stimulation sessions over 12 months

12 months

Home use, on-demand sessions

Crossover

Subjects in the SOC arm cross over to the intervention arm after the first month

11 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cala Trio

Trial Overview The Cala Trio Device is being tested in this study. It aims to provide relief from hand tremors in patients with essential tremor. The device's effectiveness and its impact on healthcare costs will be monitored over one year.

How Is the Trial Designed?

Group I: Intervention with the Cala Trio device (CTD) arm Experimental Treatment 1 Intervention

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.

Group II: Standard of Care Arm Active Control 1 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.

Who Is Running the Clinical Trial?

Cala Health, Inc.

Lead Sponsor

Trials

9

Recruited

860+

CVS Health Clinical Trial Services

Collaborator

Trials

1

Recruited

300+

CVS Clinical Trial Services

Collaborator

Trials

1

Recruited

300+

CVS Healthspire Life Sciences Solutions

Collaborator

Trials

1

Recruited

1,500+

Published Research Related to This Trial

The Itremor smartphone application effectively quantifies tremor severity in patients with essential tremor, showing good correlation with traditional clinical scores, which can be subjective and variable.

Using Itremor provides a more objective and reproducible assessment of tremor compared to clinical evaluations, potentially improving treatment adjustments for patients receiving deep brain stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Accelerometers Integrated in Smartphones to Evaluate Essential Tremor. Senova, S., Querlioz, D., Thiriez, C., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10588491/

A Randomized Pragmatic Clinical Trial - PMC This study found that adding TAPS treatment to SOC significantly improves tremor power and BF-ADL scores in patients with ET compared to SOC alone over one ...

2. calahealth.com calahealth.com/wp-content/uploads/2024/01/SD-20014-Clinical-Press-Release-JAN-2024.pdf

Cala Announces Data from Multiple Clinical Studies ... A randomized pragmatic trial by CVS Health found that adding Cala TAPS therapy to standard of care (SOC) improved outcomes over SOC alone.

3. calahealth.com calahealth.com/providers/clinical-evidence/

Clinical evidence center Consistent with previous findings, the study found Cala TAPS Therapy effectively reduces tremor with an average reduction in tremor power (measured by motion ...

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000204166

Cala Trio wrist-worn medical device for tremor ... The device measured a mean improvement of 76% in the patient's tremor. Conclusions: This case demonstrates the utility of the Cala Trio in a patient with ...

5. massdevice.com massdevice.com/cala-health-positive-essential-tremor-data/

Cala Health has positive essential tremor treatment data Data showed effective tremor reduction at a 64% average. It also showed consistent usage with no significant habituation over long-term use (up ...

6. calahealth.com calahealth.com/help-center/safety/

Safety Archives The device should NOT be used: by patients with an implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator; by ...

7. calahealth.com calahealth.com/

Cala kIQ - Cala kIQ The only FDA-cleared, wearable device that delivers effective therapy for action hand tremor in people with essential tremor and Parkinson's disease.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K203288.pdf

October 5, 2021 Cala Health, Inc. Danielle Boyd Director ... Cala Trio is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8065649/

Medical Devices for Tremor Suppression: Current Status and ... Clinically, Cala Trio is designed to replace Cala ONE for use in the transient, symptomatic relief of hand tremors in adults with ET. This device can be worn ...