What side effects are associated with this type of intervention?

Common treatments for Essential Tremor include medications like propranolol and primidone, which can cause side effects such as fatigue, dizziness, and nausea. For treatments similar to the Cala Trio Device, which uses electrical stimulation, side effects are generally minimal but can include mild skin irritation at the site of stimulation. Other neuromodulation techniques, like transcranial magnetic stimulation (TMS), may cause lightheadedness, tingling, and tinnitus. Overall, these treatments are considered safe with manageable side effects.

What prior FDA approvals exist?

The Cala Trio Device, which uses electrical stimulation to disrupt tremor signals, represents a novel approach in the treatment of Essential Tremor. Prior FDA-approved treatments for Essential Tremor primarily include pharmacologic agents such as propranolol, a beta-blocker, and primidone, an anticonvulsant. These medications help reduce tremor severity but do not involve electrical stimulation. Other treatments like deep brain stimulation (DBS) have been used for severe cases, where electrodes are implanted in the brain to modulate neural activity. The Cala Trio Device offers a non-invasive alternative by providing external neuromodulation to manage tremor symptoms.

What other types of research exist?

Promising novel alternatives to the Cala Trio Device for Essential Tremor patients include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain and has shown efficacy in reducing tremor symptoms. 2) Focused Ultrasound (FUS), a non-invasive procedure that uses focused sound waves to target and destroy small areas of brain tissue responsible for tremors. 3) Deep Brain Stimulation (DBS), which involves implanting electrodes in specific brain areas to modulate abnormal signals causing tremors. These alternatives offer different approaches to managing essential tremor and may be considered based on individual patient needs and responses.

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Behavioural Intervention

Cala Trio Device for Essential Tremor

N/A

Waitlist Available

Research Sponsored by Cala Health, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Age ≥22 years

Must not have

Evidence of Parkinson's Disease

Formal diagnosis of hyperthyroidism without evidence of treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 1, 3, 6, 9 and 12

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the specific side effects are not listed here, devices like the Cala Trio may cause discomfort at the site of application, skin irritation, or temporary increase in tremor during usage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 22 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Parkinson's Disease.

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I have been diagnosed with hyperthyroidism and have not received any treatment.

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I have received a botulinum toxin injection in my arm in the last 6 months.

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I have undergone a specific brain surgery or gamma-knife procedure.

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I have been diagnosed with and am being treated for hypothyroidism.

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I have been diagnosed with epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 1, 3, 6, 9 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 1, 3, 6, 9 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1, 3, 6, 9 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in tremor power

Secondary study objectives

Bain & Findley Activities of Daily Living (ADL) scale subset score

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention with the Cala Trio device (CTD) armExperimental Treatment1 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 ArmActive Control1 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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Cala Trio Device and similar treatments for Essential Tremor (ET) utilize electrical stimulation to modulate the peripheral and central components of the tremor network. This is achieved by stimulating sensory afferent nerve fibers at the wrist, which can disrupt the abnormal tremor signals. This mechanism is significant for ET patients as it offers a non-invasive, user-friendly option that can reduce tremor severity and improve quality of life. Other common treatments, such as deep brain stimulation (DBS), work by delivering electrical impulses to specific brain areas to regulate abnormal signals, while medications like beta-blockers and anticonvulsants aim to reduce tremor amplitude through pharmacological means. Understanding these mechanisms helps patients and clinicians choose the most appropriate and effective treatment based on individual needs and response to therapy.

Rationale and Evidence for Peripheral Nerve Stimulation for Treating Essential Tremor.