NCT04799418

STEM-PD Open Label Extension (OLE)

Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: An Open Label Extension (OLE) Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Scion NeuroStim · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to establish the safety and efficacy of extended twice daily time-varying caloric vestibular stimulation treatments for treating symptoms associated with Parkinson's disease. Only participants who completed the STEM-PD randomized controlled trial portion (NCT04797611) are eligible to participate in the open label extension portion.

Detailed description

Up to 220 participants will enter an open label extension study during which all study participants will receive active (i.e., time-varying caloric vestibular stimulation) treatment for 12 weeks (84 days). Study participants will be followed for 16 weeks (112 days) post treatment-cessation and then the twice daily active treatments will be re-introduced for the final 8 weeks (56 days).

Conditions

• Parkinson Disease
• Parkinson's Disease and Parkinsonism

Interventions

Type	Name	Description
DEVICE	Open Label Extension Study	This study will investigate the safety and efficacy of extended treatments for the management of symptoms related to PD.

Timeline

• Start date: 2022-09-15
• Primary completion: 2025-02-24
• Completion: 2025-02-24
• First posted: 2021-03-16
• Last updated: 2025-07-03
• Results posted: 2025-07-03

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study