Autologous Peripheral Nerve Grafts Into the Substantia Nigra of Subjects With PD Undergoing Deep Brain Stimulation
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | April 2013 |
| End Date: | September 2015 |
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
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.
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.
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.
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.
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
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