Clinical trial NCT02629614: Cala ONE Device for Essential Tremor
Official title: Multicenter Study of Safety and Effectiveness of Cala ONE Device for Essential Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Lead sponsor: Cala Health, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-14
Enrollment: 93
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in TETRAS Spiral Rating After Stimulation
timeFrame: Immediately before and after 40 minute stimulation session
Secondary outcomes:
measure: Change in TETRAS Spiral Rating During Stimulation
timeFrame: Immediately before and 30 minutes into stimulation session
measure: Self-report Improvement
timeFrame: Immediately before and after 40 minute stimulation session
Other outcomes:
measure: Change in Kinetic Tremor
timeFrame: Immediately before and after 40 minute stimulation session
measure: Change in Kinetic Tremor
timeFrame: Immediately before and 30 minutes into stimulation session
measure: Change in Lateral "Wing Beating" Postural Tremor
timeFrame: Immediately before and after 40 minute stimulation session
measure: Change in Lateral "Wing Beating" Postural Tremor
timeFrame: Immediately before and 30 minutes into stimulation session
measure: Change in Forward Outstretched Postural Tremor
timeFrame: Immediately before and after 40 minute stimulation session
measure: Change in Forward Outstretched Postural Tremor
timeFrame: Immediately before and 30 minutes into stimulation session
measure: Change in Bain & Findley ADL: Use a Spoon to Drink Liquid
timeFrame: Immediately before and after 40 minute stimulation session
measure: Change in Bain & Findley ADL: Hold a Cup of Liquid
timeFrame: Immediately before and after 40 minute stimulation session
measure: Change in Bain & Findley ADL: Pouring
timeFrame: Immediately before and after 40 minute stimulation session
measure: Change in Bain & Findley ADL: Dialing
timeFrame: Immediately before and after 40 minute stimulation session
measure: Change in Bain & Findley ADL: Picking up Change
timeFrame: Immediately before and after 40 minute stimulation session
measure: Change in Bain & Findley ADL: Inserting Plug Into Socket
timeFrame: Immediately before and after 40 minute stimulation session
measure: Change in Bain & Findley ADL: Unlocking
timeFrame: Immediately before and after 40 minute stimulation session
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
city: Sunnyvale
country: United States
facility: The Parkinson's Institute
state: California
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Seattle
country: United States
facility: Swedish Medical Center Seattle
state: Washington
Study officials:
affiliation: Clinical Advisor
name: Lin, MD
role: STUDY_CHAIR
References: