Autologous Peripheral Nerve Grafts Into the Substantia Nigra of Subjects With PD Undergoing Deep Brain Stimulation

NCT01833364 | Completed DMC

• 2 other identifiers: 12-1021-F6A12-1021
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

By doing this study, the investigators hope to learn provide safety data that can be used to generate a larger phase III clinical trial. If successful, it would promote the development of a new treatment for PD in which patients are able to provide their own tissue as a source of a supportive environment for the injured and dying cells and thereby possibly stopping the progression of the illness or even improve the symptoms of PD. The purpose of this research is to gather information on the safety and feasibility of nerve graft implantation is. The results of this study will be shared with the University of Kentucky, Center for Clinical and Translational Science (group providing financial support for the study) and other federal agencies, if required. The overall goal of this research is to develop a novel, regenerative treatment strategy for idiopathic Parkinson's disease (PD) that is safe, cost effective and widely available to patients.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Deep Brain Stimulation; Peripheral Nerve Graft

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of Nerve Graft Implantation

  All Adverse events will be collected from the time subject signs the consent to the time they complete study visit 12 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 STN. In addition, MRI imaging of the graft site within the substantia nigra will be compared to the contralateral, non-grafted site.

  One year

Secondary Outcomes (3)

• Peripheral Nerve Graft Efficacy -- clinical improvement

  1 year

• Peripheral Nerve Graft Efficacy -- Therapy Reduction

  1 year

• Peripheral Nerve Graft Efficacy -- Quality of Life

  1 year

Study Arms (1)

Implantation of Perpherial Nerve Graft

EXPERIMENTAL

Subjects own peripheral nerve tissue that will be used to create the graft for implantation. The autologous peripheral nerve graft will then be implanted unilaterally into the substantia nigra of the subject after the placement of DBS electrodes.

Procedure: Implantation of the Peripheral Nerve Graft

Interventions

Implantation of the Peripheral Nerve Graft PROCEDURE

The preparatory surgery for harvesting the peripheral nerve graft will take place in the operating room at the time of the Stage I surgery for the DBS procedure. The nerve exposure and preparation will take approximately 15 minutes of operating time in addition to the DBS procedure which typically takes 75-90 minutes. The implantation of the nerve graft will take place in the operating room at the end of the second stage surgery for DBS. The graft harvesting and implantation will take approximately 15 minutes in addition to the 4 hours that is needed for the DBS surgery. The subject's peripheral nerve graft will be implanted into the substantia nigra unilaterally. This is a single arm trial to assess safety and feasibility.

Also known as: Peripheral Nerve Graft

Implantation of Perpherial Nerve Graft

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elected to have DBS Surgery
• Parkinson's Disease for 5 years or more
• Ages 40-75

You may not qualify if:

• Have previously undergone PD surgery or any intracranial surgery
• Unwilling to delay taking PD medications during the study
• Unable to follow the directions of the study team
• Unable to attend all study visits
• Have participated in previous clinical studies and received an investigational product within 30 days of screening

Sponsors & Collaborators

• Craig van Horne, MD, PhD: lead
• University of Kentucky: collaborator

Study Sites (2)

University of Kentucky Medical Center

Lexington, Kentucky, 40475, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Related Publications (2)

• van Horne CG, Quintero JE, Slevin JT, Anderson-Mooney A, Gurwell JA, Welleford AS, Lamm JR, Wagner RP, Gerhardt GA. Peripheral nerve grafts implanted into the substantia nigra in patients with Parkinson's disease during deep brain stimulation surgery: 1-year follow-up study of safety, feasibility, and clinical outcome. J Neurosurg. 2018 Dec 1;129(6):1550-1561. doi: 10.3171/2017.8.JNS163222. Epub 2018 Feb 18.

  PMID: 29451447 DERIVED

• van Horne CG, Quintero JE, Gurwell JA, Wagner RP, Slevin JT, Gerhardt GA. Implantation of autologous peripheral nerve grafts into the substantia nigra of subjects with idiopathic Parkinson's disease treated with bilateral STN DBS: a report of safety and feasibility. J Neurosurg. 2017 Apr;126(4):1140-1147. doi: 10.3171/2016.2.JNS151988. Epub 2016 May 6.

  PMID: 27153166 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Craig van Horne, MD

  University of Kentucky, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 16, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 9, 2016

Record last verified: 2016-03

Locations

US (2)