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Nerve Tissue Implantation for Parkinson's Disease (GUIDE Trial)
GUIDE Trial Summary
This trialstudies a new surgery to treat Parkinson's Disease with donor tissue from the same person. 10 people will be followed for 12 months, then annually for life.
GUIDE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowGUIDE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.GUIDE Trial Design
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Who is running the clinical trial?
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- I am fit for surgery.I am not pregnant, breastfeeding, and if able to bear children, I agree to use birth control during the study.I am willing and able to undergo a specific brain scan.I am between 40 and 75 years old.My brain pathway to the substantia nigra is blocked.I have been diagnosed with Parkinson's disease.I have had surgery for Parkinson's disease or brain surgery.My sural nerve can be accessed for medical purposes.
- Group 1: Implantation of peripheral nerve tissue
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Who is eligible to take part in this clinical research?
"The requirements for inclusion into this medical trial are a diagnosis of Parkinson's disease (PD) and an age between 40 and 75. Currently, 10 individuals need to be recruited."
What ultimate goals are scientists attempting to accomplish with this clinical experiment?
"This experiment seeks to evaluate the efficacy of introducing nerve grafts into the brain, with a timeline of 12 months. Secondary objectives include assessing the number of deployment attempts necessary to deliver bilateral PNT; changes in MDS-UPDRS (Movement Disorder Society - Unified Parkinson's disease Rating Scale) Part III scores after 6 and 12 months compared to baseline; alteration in Mean change of Modified Schwab and England Scores following 6 and 12 months relative to baseline. These scales range from 0-132 or 0%-100%, respectively, where lower numbers/higher percentages indicate fewer symptoms/more independence."
What is the upper limit to the number of individuals participating in this experiment?
"Affirmative. The information provided on clinicaltrials.gov indicates that this research is now recruiting individuals for participation. It was initially posted on July 7th 2022 with the most recent update having occurred November 10th 2022, and it intends to enrol a total of 10 patients from 1 site."
Is it possible to join the current cohort of participants for this experiment?
"Affirmative, the details hosted on clinicaltrials.gov demonstrate that this medical trial is actively recruiting participants. It was first listed on July 7th 2022 and has been updated most recently on November 10th 2021. This study necessitates the enrollment of 10 patients at one location."
Is Implantation of peripheral nerve tissue a safe procedure for individuals?
"The relative safety of peripheral nerve tissue implantation is assessed at a 1 as this trial currently runs in its first phase, and thus only possesses limited data for both efficacy and security."
Do individuals aged 50 or above qualify to partake in this trial?
"This clinical trial seeks to recruit participants aged between 40 and 75 years old. Alternatively, 27 studies are available for those under 18 while 482 can be found for people over the age of 65."
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