An interventional study of Implantation of the Peripheral Nerve Graft in Parkinson's Disease, sponsored by Craig van Horne, MD, PhD. Completed at 2 sites in United States. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-03-09.
Sponsored by Craig van Horne, MD, PhD · Not applicable, Interventional, 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.
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 8 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Craig van Horne, MD, PhD is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Time frame: One year
Peripheral Nerve Graft Efficacy -- clinical improvement
Post operative data will be collected at study visit 1, 3, 6, 9 and 12 from the time of the second stage surgery. * Subjects will undergo UPDRS evaluation at each visit. This will include evaluations with the patients off medication and off stimulation as well as on medication and on stimulation. Comparisons will be evaluated for changes relating to time from implantation as well as between the implanted side vs the non-implanted side.
Time frame: 1 year
Peripheral Nerve Graft Efficacy -- Therapy Reduction
This is a composite evaluation targeting changes in medication requirements and DBS stimulation requirements. - Changes in medication dosages and stimulation parameters will be recorded at each visit (1,3,6,9,and 12 months post-implantation). Stimulation parameter changes will be evaluated from time of implantation and also compared between the grafted and non-grafted side.
Time frame: 1 year
Peripheral Nerve Graft Efficacy -- Quality of Life
Subjects will also have a formal neuropsychological and PDQ-8 examination pre-operatively and at 12 months post implantation. These tests will be used to evaluate psychological profiles and for possible changes in quality of life.
Time frame: 1 year
The record gives a start of Apr 2013, a primary completion of Jul 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Craig van Horne, MD, PhD