Cala ONE Device for Essential Tremor

NCT ID: NCT02629614

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cala ONE Device

Intervention Type: 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

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

Group Type: SHAM_COMPARATOR

Cala ONE Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cala Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin, MD

Role: STUDY_CHAIR

Clinical Advisor

Locations

UCSF

San Francisco, California, United States

The Parkinson's Institute

Sunnyvale, California, United States

Kansas University Medical Center

Kansas City, Kansas, United States

Swedish Medical Center Seattle

Seattle, Washington, United States

Countries

United States

Other Identifiers

ET-03

Identifier Type: -

Identifier Source: org_study_id