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NCT Number: NCT02629614

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.

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 22 years or older
  • A diagnosis of essential tremor as confirmed from clinical history and examination by a movement disorder neurologist
  • Signed informed consent
  • 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.
  • Score of 3 or above in any one of the items of the Bain & Findley ADL Scale

Exclusion criteria

  • Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
  • 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
  • Pregnant
  • Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
  • Peripheral neuropathy affecting the tested upper extremity
  • Alcoholism (score of 4 or higher on DSM-5)
  • Other possible causes of tremor, including Parkinson's disease, drug-induced, enhanced physiological tremor, dystonia
  • 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
  • Changes in medication for tremor within 1 month prior to study enrollment
  • Change in antidepressant medication within 3 months prior to study enrollment
  • Botulinum Toxin injection for hand tremor within 6 months prior to study enrollment
  • Current participation in any other interventional research study
  • Previous participation in any other Cala Health interventional research study
  • 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.

Treatment and study plan

Cala ONE device

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cala Health, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 14, 2015
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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