Sural Nerve Graft for Parkinson's Disease
(LEAP Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Craig van Horne, MD, PhD

Trial Summary

What is the purpose of this trial?This phase I double-blind study focuses on the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the substantia nigra area of the brain in persons who have been diagnosed with either Parkinson's disease (PD) or Multiple System Atrophy (MSA). 7 participants will be enrolled, with 4 participants receiving the graft and 3 receiving a sham surgery. Eligible participants will be early in their diagnosis with a lower burden of symptoms. Participants will be followed initially for one year after surgery.

Eligibility Criteria

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.

Inclusion Criteria

I am willing and able to undergo a specific brain scan.

I have been diagnosed with Parkinson's disease or multiple system atrophy.

Able to undergo all planned assessments

+6 more

Exclusion Criteria

Unable to undergo an MRI

Typical, nonparkinsonian syndrome ioflupane/SPECT signal

I have a significant ongoing medical or mental health issue.

+7 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Nerve Graft RecipientsExperimental Treatment1 Intervention

Group II: Placebo GroupPlacebo Group1 Intervention