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Long-Term Treatment for Parkinson's Disease

N/A

Waitlist Available

Research Sponsored by Scion NeuroStim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the RCT or OLE study trial.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a longer treatment for symptoms of Parkinson's disease is safe and effective. Only people who completed a previous trial are eligible.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects are not listed here, but generally, treatments in Parkinson's may include nausea, dizziness, sleepiness, and movement issues. The exact side effects will depend on the particular intervention being tested.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Movement Disorders

Secondary study objectives

Change from baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II

Change from baseline in the Clinical Global Impression - Improvement (CGI-I)

Change from baseline in the MDS-UPDRS Part III

+1 more

Other study objectives

Change from baseline in EncephaLogTM 10m Timed Up and Go (10m TUG)

Change from baseline in EncephaLogTM 3 meter Timed Up and Go Test

Change from baseline in EncephaLogTM finger tapping test

+17 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental Treatment 1Experimental Treatment1 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.

0 / 1Eligibility criteria met