RecruitingPhase 1NCT06683378

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

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


Sponsor

Craig van Horne, MD, PhD

Enrollment

24 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators propose a Phase I single surgical-center, double-blinded randomized parallel clinical trial involving bilateral autologous peripheral nerve tissue (PNT) delivery into the NBM or the alternate target also affecting cognition in this population, the substantia nigra (SN), to address "repair cell" support of these areas. Twenty-four participants with idiopathic Parkinson's Disease (PD) who have selected, qualified and agreed to receive as standard of care deep brain stimulation (DBS) will be enrolled and randomly allocated to receive bilateral PNT deployment to either the NBM or SN at the time of DBS surgery. Participants will be allocated equally among both assignments over the course of three years (8 Year 1, 10 Year 2, 6 Year 3). Participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment before surgery, two-weeks after surgery, and 6, 12, and 24 months after surgery.


Eligibility

Min Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether implanting a piece of your own nerve tissue into the brain during deep brain stimulation (DBS) surgery could help with both the movement and non-movement symptoms of Parkinson's disease. **You may be eligible if...** - You have been diagnosed with Parkinson's disease - You are already scheduled for deep brain stimulation (DBS) surgery - You are between 45 and 75 years old - You are healthy enough to tolerate surgery and complete all study assessments **You may NOT be eligible if...** - Any condition makes you not a good candidate for DBS surgery - You have a diagnosis of dementia - You have had previous brain surgery - You are unable to have an MRI - The surgical path to the target brain areas is blocked Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREReparative Autologous peripheral nerve tissue

At the time participants are receiving the standard of care deep brain stimulation (DBS) surgery, a standard incision on the lateral aspect near the ankle is made, the sural nerve is identified, an about 3 cm biopsy of the sural nerve is obtained and the incision is closed. From the biopsied section, the epineurium is removed, fascicles are cut, and (\~5 pieces per side; \~ 5mm length x 1.5 mm diameter: approximately 10 cubic millimeters) implanted bilaterally into the nucleus basalis of Meynert (NBM) or substantia nigra (SN).


Locations(1)

University of Kentucky

Lexington, Kentucky, United States

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NCT06683378


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