NCT03152136

A Pilot Study of the Cala ONE Device for Essential Tremor

A Pilot Study to Evaluate the Safety and Initial Effectiveness of the Cala ONE Device to Repeatably Aid in the Symptomatic Relief of Essential Tremor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Cala Health, Inc. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DEVICE	Cala ONE device	The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves.

Timeline

• Start date: 2017-07-26
• Primary completion: 2018-03-08
• Completion: 2018-03-08
• First posted: 2017-05-12
• Last updated: 2019-04-30
• Results posted: 2019-04-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study