Parkinson's Disease
Conditions
Keywords
Deep Brain Stimulation, Schwann Cells
Brief summary
This pilot study is designed to follow up on a previous, preliminary study and test the long-term safety and feasibility of the implantation of autologous peripheral nerve grafts into the substantia nigra, basal forebrain, putamen, and/or STN of participants with PD undergoing deep brain stimulation (DBS) surgery. Peripheral nerve tissue contains Schwann cells which produce growth factors that have been demonstrated to support the survival and function of neurons. Participants will serve as their own donor for the tissue, which will be implanted at the time they undergo DBS surgery.
Detailed description
The primary objective of this pilot study is to demonstrate safety of the approach: introducing a minor modification of a standard, FDA approved neurosurgical procedure in use for over a decade to implant autologous peripheral nerve into the central nervous system. As such, the study is designed to pose minimal risk and minimal inconvenience to the subjects. Additionally, the test paradigm is performed strategically to not interfere with the surgery or delivery of the scheduled clinical DBS therapy. The scientific basis for this study is that the implanted peripheral nerve tissue is naturally well suited to provide multiple growth factors that have been shown experimentally to support the survival and function of dopaminergic neurons. Central to this proposal is the hypothesis that the implanted tissue will physiologically deliver growth factors to restore to normal function the afflicted neurons found in PD. The first specific aim is to assess the feasibility and safety of the combined peripheral nerve graft/DBS surgical procedure. The second specific aim is to evaluate the long term clinical safety of the peripheral nerve implant. This pilot study will provide safety data that can be used to generate a larger phase III clinical trial. If successful, it would herald the development of a new treatment for PD in which patients are able to provide their own tissue as a source of growth factors that could arrest or reverse the ongoing cellular loss that is responsible for their devastating dysfunction.
Interventions
PROCEDUREAutologous Peripheral Nerve Graft
Implantation of Autologous Peripheral Nerve Graft into the substantia nigra, basal forebrain, putamen, and/or STN of participants with PD undergoing deep brain stimulation (DBS) surgery.
Sponsors
Craig van Horne, MD, PhD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing DBS of the STN or GPi * Between the ages of 40-75 * Able to give informed consent * Show a positive response to Sinemet (carbidopa/levodopa) * Be able to tolerate the surgical procedure
Exclusion criteria
* Any condition that would not make the subject a candidate for DBS of the STN or GPi * Under the age of 40 or over the age of 75 * Unable to give informed consent * Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 15 years | Safety and Tolerability of Nerve Graft Implantation. Adverse events will be collected in order to measure the safety and tolerability of the grafting procedure. Adverse events will be documented and compared to the known and reported adverse events of DBS of Subthalamic Nucleus (STN) or internal globus pallidus (GPi). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DaTscan assessment | 12 or 24 months | Dopamine neurodegeneration at 12 or 24 months will be assessed using DaTscan SPECT imaging and compared to scans obtained before DBS surgery. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCraig van Horne, MD, PhD
University of Kentucky
Outcome results
None listed