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Procedure
Peripheral Nerve Tissue Implantation for Parkinson's Disease (STAR Trial)
Phase 1
Waitlist Available
Led By Craig G van Horne, MD, PhD
Research Sponsored by Craig van Horne, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to tolerate the surgical procedure
Diagnosis of clinically established or clinically probable PD as defined by MDS criteria
Must not have
Dementia diagnosis
An obstructed trajectory path to the substantia nigra and nucleus basalis of Meynert
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6, 12, and 24 months compared to baseline
Awards & highlights
No Placebo-Only Group
Summary
"This trial will involve 24 participants with Parkinson's Disease who are undergoing deep brain stimulation (DBS) surgery. They will receive bilateral peripheral nerve tissue (PNT) delivery into specific brain regions to
Who is the study for?
This trial is for people with Parkinson's Disease who are already planning to get deep brain stimulation (DBS) surgery. They should be diagnosed with idiopathic Parkinson's and willing to have additional experimental treatment involving their own nerve tissue implanted in the brain.
What is being tested?
The study tests implanting a patient's own peripheral nerve tissue into two different brain areas during DBS surgery. It aims to see if this can help non-motor or motor symptoms of Parkinson’s. Participants will be randomly assigned to receive the tissue in either the NBM or SN area.
What are the potential side effects?
Since this is an early-stage trial, specific side effects aren't listed but may include typical surgical risks like infection, bleeding, and reactions related to DBS adjustments post-surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fit for surgery.
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I have been diagnosed with Parkinson's disease.
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My sural nerve can be accessed for medical procedures.
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I am between 45 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with dementia.
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My brain's pathways to certain areas are not blocked.
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I have had surgery for Parkinson's disease or brain surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6, 12, 24 months compared to baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6, 12, 24 months compared to baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants completing 12 month study visit
Study-related adverse events as assessed by MedDRA v27
Study-related serious adverse events as assessed by MedDRA v.27
+1 moreSecondary study objectives
Change in Neuropsychological diagnosis
Change in Neuropsychological domains with impairment
Mean change in Dementia Rating Scale (DSRS)
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Peripheral nerve tissue (PNT) deployment to the Substantia NigraActive Control1 Intervention
Group II: Peripheral nerve tissue (PNT) deployment to the nucleus basalis of MeynertActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Craig van Horne, MD, PhDLead Sponsor
4 Previous Clinical Trials
95 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,804 Previous Clinical Trials
28,194,875 Total Patients Enrolled
Craig G van Horne, MD, PhDPrincipal InvestigatorUniversity of Kentucky