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Cont. of a Study to Evaluate Implanting Peripheral Nerve Grafts Into Subjects With Parkinson's Disease (PD) During DBS

Active Not RecruitingPhase 1

Sponsor: Craig van Horne, MD, PhD

Conditions: Parkinson's Disease

Interventions: Autologous Peripheral Nerve Graft

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 40 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Lexington, Kentucky, United States