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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
510 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment accommodate individuals who are over four decades of age?

"Eligible participants must range between 18 to 85 years old. Those under the age of consent may be able to join one of 30 studies, while those over 65 can look into any of 496 clinical trials."

Answered by AI

Are applicants currently being accepted for participation in this experiment?

"Per the info on clinicaltrials.gov, this investigation is not presently enlisting participants. It was first posted on September 15th 2022 and lastly refreshed October 24th 2022. However, there are 499 other medical trials that currently have spots available for prospective patients."

Answered by AI

How many venues is the research project managed at?

"At present, there are 16 medical facilities participating in this research trial. Of these, Cleveland, Houston and Raleigh have been highlighted as potential options for participants; however patients should still assess the proximity of other sites to reduce travel needs if they choose to enrol."

Answered by AI

Who has the eligibility requirements necessary to participate in this trial?

"To enroll in this trial, individuals must have been diagnosed with Parkinson's disease and be between 18 - 85 years of age. The medical team is seeking to recruit 220 participants."

Answered by AI

What is the ultimate objective of this medical research?

"Per the research sponsor, Scion NeuroStim, key measurements will be taken over an 8-month interval. The primary outcome is MDS-NMS Assessment and secondary outcomes include a Change from Baseline score in MDS-UPDRS Part III (33 items ranging 0 to 132 with higher scores indicating more severe motor symptoms), a Change from Baseline score in International Parkinson & Movement Disorder Society Unified PD Rating Scale (MDS-UPDRS) Part II (13 items ranging between 0 - 52 with higher scores signifying greater impairment of activities of daily living), and lastly, Change From baseline on the Parkinson's disease Quality"

Answered by AI

Who else is applying?

What site did they apply to?
University of New Mexico
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
STEM-PD Open Label Extension (OLE)
2022. "STEM-PD Open Label Extension (OLE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04799418.
All > Parkinsons Disease > Parkinson Disease
~38 spots leftby Sep 2024
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