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
Sponsors and collaborators
Craig van Horne, MD, PhD
Lead sponsor
University of Kentucky
Sponsor institution
National Institute on Aging (NIA)
Collaborator