A Pilot Study of the Cala ONE Device for Essential Tremor (EXCITE)

Cala Health

Status

Completed

Conditions

Essential Tremor

Treatments

Device: Cala ONE device

Study type

Interventional

Funder types

Industry

Identifiers

NCT03152136

ET-13

Details and patient eligibility

About

Prospective, multi-center, randomized, controlled study designed to evaluate safety and repeatable effectiveness. Subjects will be randomized 2:1:1 to transcutaneous afferent patterned stimulation (TAPS), sham, or 'no intervention', respectively. Subjects randomized to the TAPS and sham arms will be blinded to their randomization assignments for the first two weeks of participation (controlled phase). After the first two weeks, all subjects will be crossed over to TAPS (open-label phase) for 2 weeks. During study participation, all subjects are to remain on a stable dosage of medications prescribed for the treatment of essential tremor, if applicable.

Enrollment

62 patients

Sex

All

Ages

22 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must be ≥22 and ≤80 years of age
Competent and willing to provide written, informed consent to participate in the study
A diagnosis of essential tremor as confirmed from clinical history and examination by a movement disorder neurologist
Postural, action or intention tremor severity score of 2 or above in the dominant hand/arm as measured by the CRST rating scale
Significant disability due to essential tremor (Bain & Findley score of 3 or above in any one of the hand items)
Currently or previously prescribed either propranolol or primidone for the treatment of essential tremor
Stable dose of tremor medications for 30 days prior to study entry
Stable dose of antidepressant medications for 90 days prior to study entry
Willing to comply with study protocol requirements including: remaining on a stable dosage of tremor and antidepressant medications, if applicable, during the duration of the study; no significant alcohol or caffeine consumption within 12 hours of study visits; and no significant alcohol or caffeine consumption within 4 hours of twice-daily at home assessments during the controlled phase of the study

Exclusion criteria

Moderate to severe ethanol dependence as defined by the criteria outlined in the DSM-5 (score of 4 or higher)
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
Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
Peripheral neuropathy affecting the tested upper extremity
Presence of any other neurodegenerative disease like Parkinson-plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
Anyone suspected to have the diagnosis of idiopathic Parkinson's disease (PD). This includes excluding anyone with the presence of parkinsonian features including bradykinesia rigidity, or postural instability. Subjects who exhibit only mild resting tremor but no other symptoms or signs of PD may be included.
Botulinum toxin injection for hand tremor within 6 months prior to study enrollment
Are participating or have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor
Are participating or have participated in another Cala Health clinical trial
Significant alcohol or caffeine consumption within 12 hours of study enrollment, which may confound the results of the study, where significant caffeine is considered more than 95 mg (equivalent to a cup of coffee), and significant alcohol is considered more than 14 g (equivalent to 5 oz of wine, 12 oz of beer, or 1.5 oz of distilled spirits).
Subjects unable to communicate with the investigator and staff
Any health condition that in the investigator's opinion should preclude participation in this study
Pregnancy or anticipated pregnancy during the course of the study