Using a patient's own peripheral nerve tissue during DBS to try to help Parkinson's symptoms
Official title: Phase I Randomized, Double-blind Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Nucleus Basalis of Meynert or Substantia Nigra for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery
Run by University of Kentucky · NCT06683378 · Data updated 2026-11-12
This study will test whether placing a patient's own peripheral nerve tissue into either the nucleus basalis of Meynert or the substantia nigra at the time of DBS can help cognitive or motor symptoms in people with Parkinson's disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Status | Recruiting |
| Started | July 21, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | May 28, 2030 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT06683378 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 45–75 with clinically established or probable idiopathic Parkinson's disease who are planning to undergo DBS, have no dementia, can tolerate the surgery, can undergo MRI, and have accessible sural nerve are the intended candidates.
✕Probably not a fit
Patients with dementia, prior intracranial surgery, contraindications to DBS or MRI, or an obstructed surgical trajectory to the nucleus basalis of Meynert or substantia nigra are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, double-blinded, randomized Phase I trial enrolling 24 people with idiopathic Parkinson's disease who are scheduled for standard-of-care deep brain stimulation. At the time of DBS surgery participants will be randomized to receive bilateral autologous peripheral nerve tissue (PNT) implants to either the nucleus basalis of Meynert or the substantia nigra. The trial is designed to test feasibility and safety and to collect preliminary data on neurocognitive, motor, activities of daily living, and quality of life outcomes. Participants will be followed at two weeks and at 6, 12, and 24 months after surgery to track clinical responses and adverse events.
Why it matters
Potential benefit: If successful, the procedure could provide local repair-support that improves cognition or motor function and prolongs or enhances the benefits of DBS for some patients.
How similar studies have gone: Implanting autologous peripheral nerve tissue into these brain targets is novel in humans, while other early-phase cell- and tissue-based therapies and adjunct DBS approaches have produced only preliminary and mixed results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Undergoing DBS * Diagnosis of clinically established or clinically probably PD as defined by MDS criteria * Age 45-75, inclusive * Able to tolerate the surgical procedure * Able to undergo all planned assessments * Available access to the sural nerve Exclusion Criteria: * Any condition that would not make the subject a candidate for DBS * Dementia diagnosis * Previous PD surgery or intracranial surgery * Unable to undergo an MRI * An obstructed trajectory path to the substantia nigra and nucleus basalis of Meynert
Where it's running
-
University of Kentucky
Lexington, Kentucky, United States Recruiting
Study contacts
- Principal investigator: Craig G van Horne, MD, PhD — University of Kentucky
- Study coordinator: Jaimie Hixson
- Email: jaimie.henderson@uky.edu
- Phone: 8593231908
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.