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Sural Nerve Graft for Parkinson's Disease (LEAP Trial)
Phase 1
Waitlist Available
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
Diagnosis of clinically established or clinically probable PD or MSA as defined by MDS criteria
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III = 20 points and = 35 points off anti-parkinsonian medication for PD or MDS-Unified Multiple System Atrophy Rating Scale (UMSARS) = 30 points off anti-parkinsonian medication
Must not have
An obstructed trajectory path to the substantia nigra
Significant microvascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 6 months, and 12 months
Summary
This trial aims to test the safety and feasibility of implanting a person's own nerve tissue into a specific area of the brain for individuals diagnosed with Parkinson's disease or Multiple System Atrophy. Seven participants
Who is the study for?
This trial is for early-stage Parkinson's Disease or Multiple System Atrophy patients with mild symptoms. It involves a surgical procedure where nerve tissue from the patient's own body is implanted into their brain, specifically in an area called substantia nigra.
What is being tested?
The study tests the safety of transplanting one's own sural nerve to the brain region affected by Parkinson's and MSA versus a sham surgery (a pretend operation). Out of 7 participants, 4 will get the actual surgery and 3 will have sham surgery, followed up for one year.
What are the potential side effects?
Potential side effects may include typical surgical risks like infection, bleeding, or reaction to anesthesia. Since it’s a new procedure specific to neurological conditions, there might be unknown risks affecting movement or other brain functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Parkinson's disease or multiple system atrophy.
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My Parkinson's or Multiple System Atrophy symptoms are moderate without medication.
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I am willing and able to undergo a specific brain scan.
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I am between 40 and 75 years old.
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My sural nerve can be accessed for medical purposes.
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My condition has been diagnosed for over 2 years.
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My Parkinson's symptoms are mild without medication.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My brain pathway to the substantia nigra is blocked.
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I have significant small blood vessel disease.
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I have had surgery for Parkinson's disease or brain surgery.
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I am currently taking medication for mental health issues.
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I have a significant ongoing medical or mental health issue.
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I am taking blood thinners that are not aspirin.
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I am not pregnant, breastfeeding, and if capable of becoming pregnant, I agree to use birth control during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 weeks, 6 months, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks, 6 months, and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Meet recruitment goal
Secondary study objectives
Change in Neuropsychological diagnosis
Duration of procedure
Length of hospital admission
+18 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nerve Graft RecipientsExperimental Treatment1 Intervention
Group II: Placebo GroupPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
University of Kentucky CCTSUNKNOWN
1 Previous Clinical Trials
60 Total Patients Enrolled
Craig van Horne, MD, PhDLead Sponsor
4 Previous Clinical Trials
112 Total Patients Enrolled