Cala ONE Device for Essential Tremor

• 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: Cala Health, Inc.
• Information provided by (Responsible Party): Cala Health, Inc.

Tracking Information

• First Submitted Date: December 8, 2015
• First Posted Date: December 14, 2015
• Results First Submitted Date: June 1, 2023
• Results First Posted Date: July 18, 2023
• Last Update Posted Date: July 18, 2023
• Study Start Date: April 2016
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 26, 2023)

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.

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: June 26, 2023)

• 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.
• 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).

• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: June 26, 2023)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cala ONE Device for Essential Tremor
• Official Title: Multicenter Study of Safety and Effectiveness of Cala ONE Device for Essential Tremor
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Essential Tremor

Intervention

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.

Study Arms

• 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.
  Intervention: Device: Cala ONE Device
• Sham Comparator: Sham Stimulation
  0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device.
  Intervention: Device: Cala ONE Device

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 16, 2018): 93
• Original Enrollment: Not Provided
• Actual Study Completion Date: November 2016
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02629614
• Other Study ID Numbers: ET-03
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Data will be published, but no PHI will be made available.

• Current Responsible Party: Cala Health, Inc.
• Original Responsible Party: [Redacted]
• Current Study Sponsor: Cala Health, Inc.
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided

Investigators

• Study Chair: Lin, MD; Clinical Advisor

• PRS Account: Cala Health, Inc.
• Verification Date: June 2023