Cala ONE Device for Essential Tremor

Completed · Not applicable · Has a placebo group

Conditions studied: Essential Tremor

In brief

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.

Key facts

Study ID

NCT02629614

Run by

Cala Health, Inc.

People needed

93

Starts

2016-04-01

Expected to finish

2016-11-01

Last updated by the study team

2023-07-18

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.