Back to resultsCala ONE Device for Essential Tremor
Primary Purpose
Essential Tremor
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cala ONE Device
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor
Eligibility Criteria
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.
Sites / Locations
- UCSF
- The Parkinson's Institute
- Kansas University Medical Center
- Swedish Medical Center Seattle
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
TAPS Stimulation
Sham Stimulation
Arm Description
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.
0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02629614
Brief Title
Cala ONE Device for Essential Tremor
Official Title
Multicenter Study of Safety and Effectiveness of Cala ONE Device for Essential Tremor
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cala Health, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAPS Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device.
Intervention Type
Device
Intervention Name(s)
Cala ONE Device
Intervention Description
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 Outcome Measure Information:
Title
Change in TETRAS Spiral Rating After Stimulation
Description
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.
Time Frame
Immediately before and after 40 minute stimulation session
Secondary Outcome Measure Information:
Title
Change in TETRAS Spiral Rating During Stimulation
Description
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.
Time Frame
Immediately before and 30 minutes into stimulation session
Title
Self-report Improvement
Description
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).
Time Frame
Immediately before and after 40 minute stimulation session
Other Pre-specified Outcome Measures:
Title
Change in Kinetic Tremor
Description
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.
Time Frame
Immediately before and after 40 minute stimulation session
Title
Change in Kinetic Tremor
Description
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.
Time Frame
Immediately before and 30 minutes into stimulation session
Title
Change in Lateral "Wing Beating" Postural Tremor
Description
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.
Time Frame
Immediately before and after 40 minute stimulation session
Title
Change in Lateral "Wing Beating" Postural Tremor
Description
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.
Time Frame
Immediately before and 30 minutes into stimulation session
Title
Change in Forward Outstretched Postural Tremor
Description
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.
Time Frame
Immediately before and after 40 minute stimulation session
Title
Change in Forward Outstretched Postural Tremor
Description
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.
Time Frame
Immediately before and 30 minutes into stimulation session
Title
Change in Bain & Findley ADL: Use a Spoon to Drink Liquid
Description
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.
Time Frame
Immediately before and after 40 minute stimulation session
Title
Change in Bain & Findley ADL: Hold a Cup of Liquid
Description
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.
Time Frame
Immediately before and after 40 minute stimulation session
Title
Change in Bain & Findley ADL: Pouring
Description
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.
Time Frame
Immediately before and after 40 minute stimulation session
Title
Change in Bain & Findley ADL: Dialing
Description
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.
Time Frame
Immediately before and after 40 minute stimulation session
Title
Change in Bain & Findley ADL: Picking up Change
Description
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.
Time Frame
Immediately before and after 40 minute stimulation session
Title
Change in Bain & Findley ADL: Inserting Plug Into Socket
Description
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.
Time Frame
Immediately before and after 40 minute stimulation session
Title
Change in Bain & Findley ADL: Unlocking
Description
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.
Time Frame
Immediately before and after 40 minute stimulation session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin, MD
Organizational Affiliation
Clinical Advisor
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
The Parkinson's Institute
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94085
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66103
Country
United States
Facility Name
Swedish Medical Center Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be published, but no PHI will be made available.
Learn more about this trial
Cala ONE Device for Essential Tremor
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