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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Movement Disorders
Secondary outcome measures
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 outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Scion NeuroStimLead Sponsor
13 Previous Clinical Trials
465 Total Patients Enrolled

Media Library

Open Label Extension Study Clinical Trial Eligibility Overview. Trial Name: NCT04799418 — N/A
Parkinson's Disease Research Study Groups: Experimental Treatment 1
Parkinson's Disease Clinical Trial 2023: Open Label Extension Study Highlights & Side Effects. Trial Name: NCT04799418 — N/A
Open Label Extension Study 2023 Treatment Timeline for Medical Study. Trial Name: NCT04799418 — N/A
~19 spots leftby Sep 2024
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