Prospective Study for Symptomatic Relief of ET With Cala Therapy

NCT ID: NCT03597100

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 263 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-14
• Study Completion Date: 2019-05-29

Brief Summary

Prospective, multi-center, single-arm, non-significant risk study designed to evaluate the Cala TWO device. Subjects will be screened for eligibility and fitted with a Cala TWO device. Subjects will wear the device at home for a period of 3 months, during which they will be asked to stimulate their dominant hand twice a day. The stimulation amplitude will be based on each subject's stimulation threshold. Subjects will have in clinic assessments at enrollment, month 1 and 3.

Conditions

Essential Tremor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cala TWO

Two 40-minute stimulation sessions daily, separated by at least two hours

Group Type: EXPERIMENTAL

Cala TWO

Intervention Type: DEVICE

Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves

Interventions

Cala TWO

Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Must be ≥22 years of age
• Competent and willing to provide written, informed consent to participate in the study
• A diagnosis of essential tremor as confirmed from clinical history and examination by a movement disorder neurologist
• A tremor severity score of 2 or above in the dominant hand/arm as measured by any one of the TETRAS upper limb items and a minimum subset score of 6 across all upper limb items
• Significant disability due to essential tremor (Bain & Findley score of 3 or above in any one of the upper limb items and a minimum subset score of 8 across all upper limb items)
• Stable dose of tremor medications, if applicable, for 30 days prior to study entry
• Stable dose of antidepressant medications, if applicable, for 90 days prior to study entry
• Willing to comply with study protocol requirements including:

• remaining on a stable dosage of tremor and antidepressant medications, if applicable, during the duration of the study
• no significant alcohol or caffeine consumption within 8 hours prior to study visits
• no usage of the Cala TWO device within 8 hours prior to study visits

Exclusion Criteria

• Moderate to severe ethanol dependence as defined by the criteria outlined in the DSM-5 (score of 4 or higher)
• Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator, or implanted metal in the wrist to be stimulated
• Previous thalamotomy procedure, including stereotactic thalamotomy, gamma knife radiosurgical thalamotomy, and focused ultrasound for the treatment of tremor
• Suspected or diagnosed epilepsy or other seizure disorder
• Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
• Peripheral neuropathy affecting the tested upper extremity
• Presence of any other neurodegenerative disease like Parkinson-plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
• Anyone suspected to have the diagnosis of idiopathic Parkinson's disease (PD). This includes excluding anyone with the presence of parkinsonian features including bradykinesia rigidity, or postural instability. Subjects who exhibit only mild resting tremor but no other symptoms or signs of PD may be included.
• Botulinum toxin injection for hand tremor within 6 months prior to study enrollment
• Are participating or have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor
• Significant alcohol or caffeine consumption within 8 hours prior to study enrollment, which may confound the results of the study, where significant caffeine is considered more than 95 mg (equivalent to a cup of coffee), and significant alcohol is considered more than 14 g (equivalent to 5 oz of wine, 12 oz of beer, or 1.5 oz of distilled spirits).
• Subjects unable to communicate with the investigator and staff
• Any health condition that in the investigator's opinion should preclude participation in this study
• Pregnancy or anticipated pregnancy during the course of the study

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cala Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Barrow Neurological Institute (Dignity Health)

Phoenix, Arizona, United States

USC

Los Angeles, California, United States

Parkinson's Institute and Clinical Center

Mountain View, California, United States

University of California San Francisco

San Francisco, California, United States

Pacific Neuroscience Institute

Santa Monica, California, United States

Rocky Mountain Movement Disorders Center

Denver, Colorado, United States

Hospital for Special Care

New Britain, Connecticut, United States

Medstar Gerogetown Health Institute

Georgetown, District of Columbia, United States

Parkinson's Center

Boca Raton, Florida, United States

USF

Tampa, Florida, United States

Augusta University

Augusta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Kansas University Medical Center

Kansas City, Kansas, United States

Kaiser Mid-Atlantic Group

Largo, Maryland, United States

Deaconess Medical Center

Boston, Massachusetts, United States

Henry Ford Health System

West Bloomfield, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Advanced Neurology Specialists

Great Falls, Montana, United States

Parkinson's Disease and Movement Disorders Center of Long Island

Long Island City, New York, United States

Mount Sinai & Beth Isreal

New York, New York, United States

Duke University

Durham, North Carolina, United States

Wake Forest

Raleigh, North Carolina, United States

River Hills Neuroscience

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

University Of Pennsylvania Medicine

Philadelphia, Pennsylvania, United States

Jefferson University

Philadelphia, Pennsylvania, United States

University of Texas Southwestern

Dallas, Texas, United States

Texas Movement Disorder Specialist

Georgetown, Texas, United States

Houston Methodist

Houston, Texas, United States

Central Texas Neurology Consultants

Round Rock, Texas, United States

Swedish

Bellevue, Washington, United States

EvergreenHealth Medical Center

Kirkland, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ET-14

Identifier Type: -

Identifier Source: org_study_id