Cala ONE Device for Essential Tremor

NCT02629614 | Completed Results FDA Device

• 1 other identifier: ET-03
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 4

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.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in TETRAS Spiral Rating During Stimulation

  Immediately before and 30 minutes into stimulation session

• Self-report Improvement

  Immediately before and after 40 minute stimulation session

Other Outcomes (13)

• Change in Kinetic Tremor

  Immediately before and after 40 minute stimulation session

• Change in Kinetic Tremor

  Immediately before and 30 minutes into stimulation session

• Change in Lateral "Wing Beating" Postural Tremor

  Immediately before and after 40 minute stimulation session

Study Arms (2)

TAPS Stimulation

EXPERIMENTAL

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

Sham Stimulation

SHAM COMPARATOR

0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device.

Device: Cala ONE Device

Interventions

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.

Sham Stimulation; TAPS Stimulation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cala Health, Inc.: lead

Study Sites (4)

UCSF

San Francisco, California, 94121, United States

Location

The Parkinson's Institute

Sunnyvale, California, 94085, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66103, United States

Location

Swedish Medical Center Seattle

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Sr. Director of Clinical Operations
• Organization: Cala Health

vivien@calahealth.com

6506515296

Study Officials

• Lin, MD

  Clinical Advisor

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 14, 2015
• Study Start: April 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: July 18, 2023
• Results First Posted: July 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)