NCT05012579

Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Parkinson's Disease (PD) Related Action Tremor

A Study of Safety and Efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Action Tremor in Parkinson's Disease (PD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cala Health, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

Demonstrate safety and efficacy of TAPS delivered by a Cala device as a treatment for action tremor in subjects with Parkinson's disease hand tremor

Detailed description

40 patients with PD with at least mild postural tremor were enrolled in a four-week, prospective, single-arm, open-label study of twice daily TAPS therapy. Due to the COVID-19 pandemic, TAPS devices were shipped to patients to run the study remotely. Unsupervised motion assessments were captured at home, and at the beginning and end of the four weeks by telemedicine.

Conditions

• Parkinson Disease

Interventions

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

Timeline

• Start date: 2020-11-11
• Primary completion: 2021-03-12
• Completion: 2021-03-12
• First posted: 2021-08-19
• Last updated: 2024-02-13
• Results posted: 2024-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study