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

276 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a wearable device called Cala Trio that sends electrical signals to the wrist to reduce hand tremors in adults with essential tremor. The device aims to help those whose daily activities are affected by hand shaking. It works by calming the nerves and muscles in the hand.

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 data supports the effectiveness of the Cala Trio treatment for essential tremor?

The Cala Trio device, which is worn on the wrist, has been recognized for its ability to control arm tremors in essential tremor by stimulating peripheral nerves with high-frequency pulses. This method of peripheral nerve stimulation has gained attention for its potential to manage symptoms effectively. ^{1 2 3 4 5}

Is the Cala Trio device safe for humans?

The Cala system, a device worn around the wrist to treat arm tremors, has been cleared by the FDA, indicating it meets safety standards. Additionally, a study on a similar vibrational device for essential tremor found it to be safe, with no serious adverse events reported. ^{1 6 7 8 9}

How does the Cala Trio treatment for essential tremor differ from other treatments?

The Cala Trio is unique because it is a wearable device worn around the wrist that uses high-frequency pulses to stimulate the peripheral nerves, specifically the median and radial nerves, to control arm tremors. This approach is different from traditional medications or surgeries, as it targets the nerves directly with non-invasive electrical stimulation tailored to the individual's tremor frequency. ^{1 9 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Rationale and Evidence for Peripheral Nerve Stimulation for Treating Essential Tremor. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Shaky drawing: what is the rate of decline during prospective follow-up of essential tremor? [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Essential tremor centralized brain repository: diagnostic validity and clinical characteristics of a highly selected group of essential tremor cases. [2007]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation of the Caudal Zona Incerta: Tremor Control in Relation to the Location of Stimulation Fields. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Using the Accelerometers Integrated in Smartphones to Evaluate Essential Tremor. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Medical Devices for Tremor Suppression: Current Status and Future Directions. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Prevalence of essential tremor: a door-to-door survey in bidasoa, spain. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Local Vibrational Therapy for Essential Tremor Reduction: A Clinical Study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Adapted Feeding Utensils for People With Parkinson's-Related or Essential Tremor. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Wearable sensors during drawing tasks to measure the severity of essential tremor. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Digitizing Tablet and Fahn-Tolosa-Marín Ratings of Archimedes Spirals have Comparable Minimum Detectable Change in Essential Tremor. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Three-dimensional measurement of essential tremor. [2019]