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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age45-75
SponsorCraig van Horne, MD, PhD

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Reparative Autologous peripheral nerve tissue

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Craig van Horne, MD, PhD

Lead sponsor

University of Kentucky

Sponsor institution

National Institute on Aging (NIA)

Collaborator