Long-Term Treatment for Parkinson's Disease

Recruiting at 15 trial locations

Overseen By Jemica Warren

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Scion NeuroStim

Disqualifiers: Pregnancy, Incomplete STEM-PD RCT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

148 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for people who have Parkinson's Disease and were part of the earlier STEM-PD RCT trial. They must be able to consent to participate and commit to attending all study visits.

Inclusion Criteria

Participants must be willing and able to give consent to participate in the study trial.

Completion of the study activities in the STEM-PD RCT trial

Exclusion Criteria

Participant anticipates being unable to attend all visits and complete all study activities in both the RCT and OLE study trial

I am not pregnant nor planning to become pregnant during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension Treatment

Participants receive twice daily treatments using a non-invasive brainstem modulation device for 12 weeks

12 weeks

Self-administered at home

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Re-introduction of Treatment

Twice daily treatments are re-introduced for an additional 8 weeks

8 weeks

Self-administered at home

Treatment Details

Interventions

• Open Label Extension Study

Trial Overview The trial is testing the safety and effectiveness of a treatment given twice daily for Parkinson's symptoms, but only those who completed the prior STEM-PD RCT can join this extension study.

Participant Groups

Group I: Experimental Treatment 1 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Scion NeuroStim

Lead Sponsor

Trials

14

Recruited

550+