NCT04797611

STEM-Parkinson's Disease

Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: A Randomized Controlled Trial (RCT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Scion NeuroStim · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blinded, controlled, and randomized clinical trial (RCT) to establish the safety and efficacy of a non-invasive neuromodulation device for treating symptoms associated with Parkinson's disease.

Detailed description

The double-blinded, controlled, randomized clinical trial (RCT) will be conducted at 15 centers, at minimum, in the United States and the United Kingdom with the majority of centers in the United States. Up to 184 participants will enter and will self-administer treatments twice daily in their home setting over a period of 12 weeks following a 4 week baseline period. Each participant will complete 6 study visits: 3 visits at the study center and 3 visits completed in the participant's home by video call.

Conditions

• Parkinson Disease
• Parkinson's Disease and Parkinsonism

Interventions

Type	Name	Description
DEVICE	TNM Device	Study participants will self-administer \~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive tvCVS device. The device has been deemed to be a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration.

Timeline

• Start date: 2022-05-19
• Primary completion: 2024-12-06
• Completion: 2024-12-06
• First posted: 2021-03-15
• Last updated: 2025-05-13
• Results posted: 2025-05-13

Locations

23 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study