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
Craig van Horne, MD, PhD
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
- Age range
- 45–75 years
- Sex
- All
- Healthy volunteers
- No
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
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).
Location
- University of KentuckyLexington, Kentucky