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NCT Number: NCT02369003

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Peripheral Nerve Graft

Procedure

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.

Primary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 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 outcomes

  1. DaTscan assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Craig van Horne, MD, PhD

Other

Registry information

Official study title

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

Acronym: CAPNG

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2015
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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