NCT02369003Active, not recruitingPhase 1
Cont. of a Study to Evaluate Implanting Peripheral Nerve Grafts Into Subjects With Parkinson's Disease (PD) During DBS
Continuation of a Pilot Study to Evaluate the Safety and Feasibility of Implanting Autologous Peripheral Nerve Grafts in Subjects With Parkinson's Disease Undergoing Deep Brain Stimulation Surgery and Treatment
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 12 Jan 2015
- Start date
- Feb 2015
- Primary completion date
- Sept 2027
- Lead sponsor
- Craig van Horne, MD, PhD
- Diseases
- Parkinson disease
- NCT number
- NCT02369003
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 70
- From Feb 2015 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any condition that would not make the subject a candidate for DBS of the STN or GPi
Age
- Under the age of 40 or over the age of 75
Other
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.