NCT05480215

Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands

Prospective Study for Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Cala Health, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

Demonstrate safety and effectiveness of symptomatic action tremor relief in the treated hand following stimulation with the Cala Trio System using the Trio+ bands as compared to the Trio bands in adults with Essential Tremor (ET) and/or Parkinson's Disease (PD) over 2 weeks.

Detailed description

20 patients with (13 with ET and 7 with PD) with at least mild postural tremor were enrolled in a prospective, single-center, two-arm, crossover study that took place over the course of four weeks. TAPS devices were shipped to patients to run the study remotely. In the first arm of the study, subjects received TAPS treatment using the original. Cala Trio band for two weeks. Followed by a wash-out period (\> 24 hours), subjects entered the second arm and received TAPS using the Trio+ band for an additional two weeks. Unsupervised motion assessments were captured at home, and at the beginning and end of the four weeks by telemedicine.

Conditions

• Essential Tremor
• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Cala Device	transcutaneous afferent patterned stimulation (TAPS)

Timeline

• Start date: 2021-10-07
• Primary completion: 2021-12-16
• Completion: 2021-12-16
• First posted: 2022-07-29
• Last updated: 2022-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study