Tests a nerve tissue graft in early Parkinson's or multiple system atrophy
Tests a sural nerve graft placed in the brain of people with Parkinson's or MSA.
Key facts
- Who runs it
- Craig van Horne, MD, PhD
- Where
- Lexington, United StatesSee the site
- Trial code
- Registry title
- Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 7 people, planned
- Started
- 25 Feb 2025
- Expected to end
- 2 Dec 2030
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Sural Nerve Graft to the Substantia Nigra
- Sham surgery
- Record updated
- 31 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Parkinson's disease or Multiple System Atrophy who are early in their diagnosis. It tests the safety of placing a piece of the person's own nerve tissue into a brain area.
- Age
- 40 to 75 years
- Sex
- All sexes
- Disease stage
- Clinically established or probable Parkinson's disease or Multiple System Atrophy, with a disease duration of more than 2 years and a lower burden of symptoms (MDS-UPDRS Part III score of 20 to 35 off medication for Parkinson's disease, or UMSARS of 30 or less for Multiple System Atrophy).
- Earlier treatment
- People who have had Parkinson's disease surgery or brain surgery before cannot join.
- Biomarker or test result
- Must be able and willing to have an ioflupane/SPECT scan. A typical non-parkinsonian scan signal rules a person out.
Main reasons for not taking part
- Previous Parkinson's disease surgery or brain surgery
- Major medical or psychiatric disorder, including depression and psychosis
- Treatment with neuroleptics
- Cannot have an MRI, or blood thinners other than aspirin
- Pregnant, breastfeeding, or of child-bearing potential and unwilling to use birth control
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- Diagnosis of clinically established or clinically probable PD or MSA as defined by MDS criteria
- Disease duration greater than 2 years
- Age 40-75, inclusive
- MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III greater than or equal to 20 points but less than or equal to 35 points, off anti-parkinsonian medication for PD or MDS-Unified Multiple System Atrophy Rating Scale (UMSARS) less than or equal to 30 points off anti-parkinsonian medication
- No MDS-UPDRS Part III score >3 on items 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.14 while off medication
- Able and willing to undergo ioflupane/SPECT
- Able to tolerate the surgical procedure
- Able to undergo all planned assessments
- Available access to the sural nerve
Who cannot take part
- Previous PD surgery or intracranial surgery
- Other concomitant treatment with neuroleptics
- Consent capacity will be assessed and determined during and throughout a participant's neuropsychological exam. A participant who experiences a decline in consent capacity prior to surgery, will be removed from the study by the PI. A decline in consent capacity after surgery will not result in the removal of the participant in the study
- Ongoing major medical or psychiatric disorder incl. depression and psychosis
- Typical, nonparkinsonian syndrome ioflupane/SPECT signal
- Significant microvascular disease
- Unable to undergo an MRI
- An obstructed trajectory path to the substantia nigra
- Use of anticoagulants other than aspirin
- Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
Where in United States
- University of KentuckyLexington, United StatesContact: Jaimie HixsonTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Nerve Graft RecipientsTreatment being tested
Treatment: Sural Nerve Graft to the Substantia Nigra
- Placebo GroupPlacebo, for comparison
Treatment: Sham surgery
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase I Study of the Feasibility and Safety of SuraL nervE Tissue Grafting to the Substantia nigrA in Patients With Synucleinopathies (LEAP)
- Plain-language title
- Tests a nerve tissue graft in early Parkinson's or multiple system atrophyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06683365, who can take part
- Record updated
- 31 August 2026