Cala Trio Device for Essential Tremor

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Cala Health, Inc.

No Placebo Group

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.

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.

Treatment Details

Interventions

• Cala Trio (Behavioural Intervention)

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+