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

A Pilot Study to Evaluate the Safety and Feasibility of Implanting Autologous Peripheral Nerve Grafts Into the Substantia Nigra of Subjects With Parkinson's Disease Undergoing Deep Brain Stimulation Surgery and Treatment

Patrocinadores

Patrocinador principal: Craig van Horne, MD, PhD

Colaborador: University of Kentucky

Fuente University of Kentucky
Resumen breve

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.

Descripción detallada

This pilot study is designed to test the safety and feasibility of the implantation of the subject's own peripheral nerve tissue into an area of the brain called the substantia nigra. Only subjects who have elected to undergo DBS surgery will be asked to participate in this research study.

The implantation of the nerve graft will take place in the operating room at the end of the second stage surgery for DBS. Subjects will be asked to donate a piece of their own peripheral nerve tissue that will be used to create the graft for their implantation. The peripheral nerve tissue is obtained from a small incision (approximately 2 inches) above and on the outer-side of one ankle. The initial incision is created during stage I of the DBS procedure and will take place under general anesthesia. The incision will be closed with internal sutures, and a dressing will cover the incision after the procedure.

The nerve will be harvested during stage II of the DBS procedure. This involves opening the same incision using local anesthesia injected around the incision site. Once a small piece (about an inch) of the nerve is removed, the incision will be sutured closed with internal stitches. These stitches will dissolve on their own and will not need to be removed in the office.

Follow-up. Subjects will be followed in our clinic for for DBS follow-up visits and treatment, none of those visits are part of this study.

Prior to coming in for study visits subjects will need to stop taking their PD medications 12 hours before each visit. Subjects will be allowed to restart their normal PD medication during the examination.

Subjects will undergo formal Unified Parkinson's Disease Rating Scale (UPDRS) evaluations at screening and months 1, 3, 6, 9 and 12. In order to visually document potential changes in their Parkinson's Disease symptoms following their DBS surgery, we will be videotaping study related neurological testing sessions.

Subject will also be videotaped at screening, and visits 1, 3, 6, 9, 12.

A neuropsychological exam will be performed at screening and again at month 12.

Estado general Completed
Fecha de inicio April 2013
Fecha de Terminación September 2015
Fecha de finalización primaria July 2015
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Safety and Tolerability of Nerve Graft Implantation One year
Resultado secundario
Medida Periodo de tiempo
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
Inscripción 8
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Implantation of the Peripheral Nerve Graft

Descripción: 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.

Etiqueta de grupo de brazo: Implantation of Perpherial Nerve Graft

Otro nombre: Peripheral Nerve Graft

Elegibilidad

Criterios:

Inclusion Criteria:

- Elected to have DBS Surgery

- Parkinson's Disease for 5 years or more

- Ages 40-75

Exclusion Criteria:

- 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

Género: All

Edad mínima: 40 Years

Edad máxima: 75 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Craig van Horne, MD Principal Investigator University of Kentucky, Department of Neurosurgery
Ubicación
Instalaciones:
University of Kentucky Medical Center | Lexington, Kentucky, 40475, United States
University of Kentucky Medical Center | Lexington, Kentucky, 40536, United States
Ubicacion Paises

United States

Fecha de verificación

March 2016

Fiesta responsable

Tipo: Sponsor-Investigator

Afiliación del investigador: University of Kentucky

Nombre completo del investigador: Craig van Horne, MD, PhD

Título del investigador: Principal Investigator

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: Implantation of Perpherial Nerve Graft

Tipo: Experimental

Descripción: 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.

Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov