STEM-PD Open Label Extension (OLE)

Scion NeuroStim

Status: Invitation-only

Conditions: Parkinson Disease; Parkinson's Disease and Parkinsonism

Treatments: Device: Open Label Extension Study

Study type: Interventional

Funder types: Industry

Identifiers

NCT04799418

SNS-PD-003

Details and patient eligibility

About

This study seeks to establish the safety and efficacy of extended twice daily treatments for treating symptoms associated with PD. Only participants who completed the STEM-PD RCT trial are eligible for the OLE.

Full description

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

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completion of the study activities in the STEM-PD RCT trial. l.
• Participants must be willing and able to give consent to participate in the study trial.

Exclusion criteria

• Participant anticipates being unable to attend all visits and complete all study activities in both the RCT and OLE study trial.
• Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the RCT or OLE study trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 1 patient group

Experimental Treatment 1

Experimental group

Description:

Study participants will self-administer \~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration.

Treatment:

Device: Open Label Extension Study