A Study of Peripheral Nerve Tissue Implants for Parkinson's Disease During DBS Surgery
This study is looking at a new procedure for people with Parkinson's Disease (PD) who are already having Deep Brain Stimulation (DBS) surgery. Researchers will take a small piece of your own peripheral nerve tissue (from your ankle) and implant it into specific areas of your brain during your DBS surgery. This is to see if it can help support brain cells. The study aims to see if this procedure is safe, can be successfully done, and how many participants complete the 12-month study. You may be able to join if you are 45-75 years old, have Parkinson's, and are scheduled for DBS surgery. The study plans to enroll 24 participants.
- Study design
- This is a Phase 1, randomized, double-blinded study involving 24 participants. Participants will be randomly assigned to receive the nerve tissue in one of two brain areas.
- What's involved
- You would undergo a procedure to remove a small nerve sample from your ankle at the time of your DBS surgery. You would then have follow-up visits for up to 24 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for study-related adverse events from enrollment up to 24 months after the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Brain for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery
At a glance
Conditions
NCT06683378
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Kentucky
Lexington, Kentuckystudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Craig G van Horne, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Kentucky
Who to contact
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Inclusion
Exclusion
What this trial measures
- Successful deployment of bilateral peripheral nerve tissue (PNT) into the brainIntraoperative
Number of participants in each study arm who successfully receive bilateral PNT delivery.
- Number of participants completing 12 month study visit12-month study visit
Total number of participants to complete study visit by arm assignment
- Study-related adverse events as assessed by MedDRA v27Enrollment to 24-month study visit
Total number of study-related adverse events experienced by participants.
- Study-related serious adverse events as assessed by MedDRA v.27Enrollment to 24-month study visit
Total number of serious adverse events experienced by participants