Prospective Study for Symptomatic Relief of ET With Cala Therapy (PROSPECT)

Prospective Study for Symptomatic Relief of Essential Tremor With Cala Therapy

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.

Study Overview

• Status: Completed
• Conditions: Essential Tremor
• Intervention / Treatment: Device: Cala TWO

• Study Type: Interventional
• Enrollment (Actual): 263
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute (Dignity Health)
  • California
    • Los Angeles, California, United States, 90033
      • USC
    • Mountain View, California, United States, 94040
      • Parkinson's Institute and Clinical Center
    • San Francisco, California, United States, 94143
      • University of California San Francisco
    • Santa Monica, California, United States, 90404
      • Pacific Neuroscience Institute
  • Colorado
    • Denver, Colorado, United States, 80113
      • Rocky Mountain Movement Disorders Center
  • Connecticut
    • New Britain, Connecticut, United States, 06053
      • Hospital for Special Care
  • District of Columbia
    • Georgetown, District of Columbia, United States, 20007
      • Medstar Gerogetown Health Institute
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Center
    • Tampa, Florida, United States, 33612
      • USF
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Maryland
    • Largo, Maryland, United States, 20774
      • Kaiser Mid-Atlantic Group
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Deaconess Medical Center
  • Michigan
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford Health System
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • Montana
    • Great Falls, Montana, United States, 95405
      • Advanced Neurology Specialists
  • New York
    • Long Island City, New York, United States, 10017
      • Parkinson's Disease and Movement Disorders Center of Long Island
    • New York, New York, United States, 10003
      • Mount Sinai & Beth Isreal
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Raleigh, North Carolina, United States, 27157
      • Wake Forest
  • Ohio
    • Cincinnati, Ohio, United States, 45255
      • River Hills Neuroscience
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University Of Pennsylvania Medicine
    • Philadelphia, Pennsylvania, United States, 19144
      • Jefferson University
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
    • Georgetown, Texas, United States, 78628
      • Texas Movement Disorder Specialist
    • Houston, Texas, United States, 77030
      • Houston Methodist
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology Consultants
  • Washington
    • Bellevue, Washington, United States, 98004
      • Swedish
    • Kirkland, Washington, United States, 98034
      • EvergreenHealth Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cala TWO; Two 40-minute stimulation sessions daily, separated by at least two hours	Device: Cala TWO; Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TRG (Tremor Research Group) Essential Tremor Rating Assessment Scale (TETRAS) Subset Score	Tremor Research Group (TRG) Essential Tremor Rating Assessment Scale (TETRAS) subset score: TETRAS subset score relevant to the stimulated upper limb. The subset score is the sum of 6 rated tasks. Each task is rated 0 to 4, where a higher score indicates more severe tremor. Minimum subset score = 0; Maximum subset score = 24.	Baseline to 3-months
Bain & Findley Activities of Daily Living (ADL) Scale Subset Score	Bain & Findley ADL subset score relevant to the stimulated upper limb. The subset score is the sum of 8 rated tasks. Each task is rated 1 to 4, where a higher score indicates more severe tremor. Minimum subset score = 8; Maximum subset score = 32.	Baseline to 3-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinematic Measurements, as Collected With the Device During Postural Holds, Change From Pre-stimulation to Post-stimulation Across Sessions	Subjects will be prompted to perform a postural hold task before and after each stimulation session. During this task, the device will record kinematic data using on-board motion sensors to objectively assess if there are any changes in tremor level. The change in each patient's pre- and post-stimulation tremor power was defined as the median change over all valid stimulation sessions. Sample mean and standard deviations were computed using the median change value from all patients.	Average change in tremor power over 3-month study period

Collaborators and Investigators

• Sponsor: Cala Health, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2018
• Primary Completion (Actual): May 29, 2019
• Study Completion (Actual): May 29, 2019

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Tremor; Essential Tremor
• Other Study ID Numbers: ET-14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No