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Cala ONE Device for Essential Tremor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02629614
Recruitment Status : Completed
First Posted : December 14, 2015
Results First Posted : July 18, 2023
Last Update Posted : July 18, 2023
Sponsor:
Information provided by (Responsible Party):
Cala Health, Inc.

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Essential Tremor Device: Cala ONE Device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Study of Safety and Effectiveness of Cala ONE Device for Essential Tremor
Study Start Date : April 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in TETRAS Spiral Rating After Stimulation [ Time Frame: Immediately before and after 40 minute stimulation session ]

    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.



Secondary Outcome Measures :
  1. Change in TETRAS Spiral Rating During Stimulation [ Time Frame: Immediately before and 30 minutes into stimulation session ]

    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.


  2. Self-report Improvement [ Time Frame: Immediately before and after 40 minute stimulation session ]
    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).


Other Outcome Measures:
  1. Change in Kinetic Tremor [ Time Frame: Immediately before and after 40 minute stimulation session ]

    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.


  2. Change in Kinetic Tremor [ Time Frame: Immediately before and 30 minutes into stimulation session ]

    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.


  3. Change in Lateral "Wing Beating" Postural Tremor [ Time Frame: Immediately before and after 40 minute stimulation session ]

    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.


  4. Change in Lateral "Wing Beating" Postural Tremor [ Time Frame: Immediately before and 30 minutes into stimulation session ]

    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.


  5. Change in Forward Outstretched Postural Tremor [ Time Frame: Immediately before and after 40 minute stimulation session ]

    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.


  6. Change in Forward Outstretched Postural Tremor [ Time Frame: Immediately before and 30 minutes into stimulation session ]

    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.


  7. Change in Bain & Findley ADL: Use a Spoon to Drink Liquid [ Time Frame: Immediately before and after 40 minute stimulation session ]

    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.


  8. Change in Bain & Findley ADL: Hold a Cup of Liquid [ Time Frame: Immediately before and after 40 minute stimulation session ]

    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.


  9. Change in Bain & Findley ADL: Pouring [ Time Frame: Immediately before and after 40 minute stimulation session ]

    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.


  10. Change in Bain & Findley ADL: Dialing [ Time Frame: Immediately before and after 40 minute stimulation session ]

    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.


  11. Change in Bain & Findley ADL: Picking up Change [ Time Frame: Immediately before and after 40 minute stimulation session ]

    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.


  12. Change in Bain & Findley ADL: Inserting Plug Into Socket [ Time Frame: Immediately before and after 40 minute stimulation session ]

    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.


  13. Change in Bain & Findley ADL: Unlocking [ Time Frame: Immediately before and after 40 minute stimulation session ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629614


Locations
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United States, California
UCSF
San Francisco, California, United States, 94121
The Parkinson's Institute
Sunnyvale, California, United States, 94085
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66103
United States, Washington
Swedish Medical Center Seattle
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Cala Health, Inc.
Investigators
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Study Chair: Lin, MD Clinical Advisor
More Information
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Responsible Party: Cala Health, Inc.
ClinicalTrials.gov Identifier: NCT02629614    
Other Study ID Numbers: ET-03
First Posted: December 14, 2015    Key Record Dates
Results First Posted: July 18, 2023
Last Update Posted: July 18, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be published, but no PHI will be made available.

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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
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Movement Disorders
Central Nervous System Diseases