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Nerve Grafts + DBS Surgery for Parkinson's Disease (CAPNG Trial)
Phase 1
Waitlist Available
Research Sponsored by Craig van Horne, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Show a positive response to Sinemet (carbidopa/levodopa)
Be able to tolerate the surgical procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
CAPNG Trial Summary
This trial will test if it is safe to implant autologous peripheral nerve grafts into the substantia nigra, basal forebrain, putamen, and/or STN of participants with PD undergoing deep brain stimulation (DBS) surgery.
Who is the study for?
This trial is for people aged 40-75 with Parkinson's Disease who are already getting deep brain stimulation (DBS) surgery and respond well to Sinemet. They must be able to consent and handle the surgery. It's not for those under 40 or over 75, pregnant or breastfeeding women, or anyone unable to use birth control during the study.Check my eligibility
What is being tested?
The study tests implanting nerve grafts from a patient's own body into their brain during DBS surgery. These grafts contain cells that might help neurons survive and function better in Parkinson’s patients.See study design
What are the potential side effects?
Since this is a surgical procedure involving implantation of nerve tissue, potential side effects may include infection, bleeding, reaction at the implant site, and typical risks associated with any surgical intervention.
CAPNG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I respond well to Sinemet medication.
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I am medically fit for surgery.
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I am receiving deep brain stimulation in specific brain areas.
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I am between 40 and 75 years old.
CAPNG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Secondary outcome measures
DaTscan assessment
CAPNG Trial Design
1Treatment groups
Experimental Treatment
Group I: Peripheral Nerve GraftExperimental Treatment1 Intervention
The intervention includes the surgical implantation of autologous peripheral nerve graft into the substantia nigra, basal forebrain, putamen, and/or STN of participants with Parkinson's Disease that are undergoing Deep Brain Stimulation (DBS).
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Who is running the clinical trial?
Craig van Horne, MD, PhDLead Sponsor
2 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I respond well to Sinemet medication.I am not pregnant, breastfeeding, and if capable of becoming pregnant, I agree to use birth control during the study.I am medically fit for surgery.I am not eligible for deep brain stimulation.I am unable to understand and agree to the study's details on my own.I am receiving deep brain stimulation in specific brain areas.I am either younger than 40 or older than 75.I am between 40 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Peripheral Nerve Graft
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this investigative trial opened recruitment yet?
"The clinical trial in question, initially announced on February 1st 2015 and last modified November 10th 2022 according to the information provided by clinicaltrials.gov, is not enrolling patients at this juncture; nonetheless, there are 484 other studies actively searching for participants."
Answered by AI
Has Autologous Peripheral Nerve Graft been approved by the FDA?
"Autologous Peripheral Nerve Grafts have limited evidence to support their safety and efficacy, scoring a 1 on our team's scale of risk."
Answered by AI
Is the recruitment of participants aged eighty-five or older a component of this experiment?
"For this study, individuals aged between 40 and 75 are being recruited as participants."
Answered by AI
What are the criteria for participation in this research endeavor?
"In order to take part in this medical trial, interested parties must have been diagnosed with Parkinson's disease (PD) and be between the ages of 40-75. Currently, 70 participants are being sought after for enrolment."
Answered by AI
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