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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 will test a new device to see if it relieves hand tremor in adults with essential tremor. It will also track total healthcare costs over a 12-month period.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in tremor power
Secondary outcome measures
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.

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.

Find a Location

Who is running the clinical trial?

CVS Health Clinical Trial ServicesUNKNOWN
CVS Clinical Trial ServicesUNKNOWN
Cala Health, Inc.Lead Sponsor
8 Previous Clinical Trials
558 Total Patients Enrolled
5 Trials studying Essential Tremor
458 Patients Enrolled for Essential Tremor

Media Library

Cala Trio (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05540626 — N/A
Essential Tremor Research Study Groups: Standard of Care Arm, Intervention with the Cala Trio device (CTD) arm
Essential Tremor Clinical Trial 2023: Cala Trio Highlights & Side Effects. Trial Name: NCT05540626 — N/A
Cala Trio (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05540626 — N/A
Essential Tremor Patient Testimony for trial: Trial Name: NCT05540626 — N/A
~71 spots leftby Jul 2025