Cala ONE Device for Essential Tremor

Multicenter Study of Safety and Effectiveness of Cala ONE Device for Essential Tremor

This study evaluates the safety and effectiveness of the Cala ONE device to aid in the symptomatic relief of hand tremors in adult essential tremor subjects. This study is a prospective, randomized, double-blinded, sham-controlled study.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121
      • UCSF
    • Sunnyvale, California, United States, 94085
      • The Parkinson's Institute
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • Kansas University Medical Center
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center Seattle

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. 22 years or older
2. A diagnosis of essential tremor as confirmed from clinical history and examination by a movement disorder neurologist
3. Signed informed consent
4. At least one hand exhibiting kinetic tremor ≥ 2 as assessed by the TETRAS Archimedes spiral task completed during the baseline evaluation, as assessed by the Investigator in-person.
5. Score of 3 or above in any one of the items of the Bain & Findley ADL Scale

Exclusion Criteria:

1. Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
2. Previous thalamotomy procedure, including Stereotactic Thalamotomy, Gamma Knife Radiosurgical Thalamotomy, and focused ultrasound, for the treatment of tremor
3. Suspected or diagnosed epilepsy or other seizure disorder
4. Pregnant
5. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
6. Peripheral neuropathy affecting the tested upper extremity
7. Alcoholism (score of 4 or higher on DSM-5)
8. Other possible causes of tremor, including Parkinson's disease, drug-induced, enhanced physiological tremor, dystonia
9. Other neurodegenerative disease like Parkinson-plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and cortical basal ganglionic degeneration
10. Changes in medication for tremor within 1 month prior to study enrollment
11. Change in antidepressant medication within 3 months prior to study enrollment
12. Botulinum Toxin injection for hand tremor within 6 months prior to study enrollment
13. Current participation in any other interventional research study
14. Previous participation in any other Cala Health interventional research study
15. Alcohol or caffeine consumption within 12 hours of study enrollment

Subjects already taking medications for their essential tremor will remain on their medications during the study with no changes in medication type or dosage levels.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAPS Stimulation; Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device.	Device: Cala ONE Device; The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Sham Comparator: Sham Stimulation; 0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device.	Device: Cala ONE Device; The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in TETRAS Spiral Rating After Stimulation	The primary effectiveness variable is the change in tremor severity immediately after the stimulation session compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.	Immediately before and after 40 minute stimulation session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in TETRAS Spiral Rating During Stimulation	An additional analysis variable is the change in tremor severity during the stimulation session (30 minutes into stimulation session) compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.	Immediately before and 30 minutes into stimulation session
Self-report Improvement	The percentage of subjects in the treatment group indicating improvement on the CGI-I Scale will be compared to the sham group. The Clinical Global Impression - Improvement (GGI-I) scale evaluates a clinician's rating of tremor improvement noted in the subject, as a result of the treatment. The scale ranges from 1 (very much improved) to 7 (very much worse).	Immediately before and after 40 minute stimulation session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Kinetic Tremor	The change in tremor severity on the kinetic tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.	Immediately before and after 40 minute stimulation session
Change in Kinetic Tremor	The change in tremor severity on the kinetic tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.	Immediately before and 30 minutes into stimulation session
Change in Lateral "Wing Beating" Postural Tremor	The change in tremor severity in the lateral "wing beating" postural tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.	Immediately before and after 40 minute stimulation session
Change in Lateral "Wing Beating" Postural Tremor	The change in tremor severity in the lateral "wing beating" postural tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.	Immediately before and 30 minutes into stimulation session
Change in Forward Outstretched Postural Tremor	The change in tremor severity on outstretched tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.	Immediately before and after 40 minute stimulation session
Change in Forward Outstretched Postural Tremor	The change in tremor severity on outstretched tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.	Immediately before and 30 minutes into stimulation session
Change in Bain & Findley ADL: Use a Spoon to Drink Liquid	The change in tremor severity on drinking liquid with a spoon as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.	Immediately before and after 40 minute stimulation session
Change in Bain & Findley ADL: Hold a Cup of Liquid	The change in tremor severity on holding a cup of liquid as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.	Immediately before and after 40 minute stimulation session
Change in Bain & Findley ADL: Pouring	The change in tremor severity on pouring as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.	Immediately before and after 40 minute stimulation session
Change in Bain & Findley ADL: Dialing	The change in tremor severity on dialing a telephone as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.	Immediately before and after 40 minute stimulation session
Change in Bain & Findley ADL: Picking up Change	The change in tremor severity on picking up change as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.	Immediately before and after 40 minute stimulation session
Change in Bain & Findley ADL: Inserting Plug Into Socket	The change in tremor severity on inserting a plug into a socket as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.	Immediately before and after 40 minute stimulation session
Change in Bain & Findley ADL: Unlocking	The change in tremor severity on unlocking a lock with a key as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.	Immediately before and after 40 minute stimulation session

Collaborators and Investigators

• Sponsor: Cala Health, Inc.
• Investigators: Study Chair: Lin, MD, Clinical Advisor

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: December 10, 2015
• First Posted (Estimated): December 14, 2015

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 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-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be published, but no PHI will be made available.

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