Nerve Grafts + DBS Surgery for Parkinson's Disease

(CAPNG Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Craig van Horne, MD, PhD

Must be taking: Sinemet

Disqualifiers: Pregnancy, Lactation, Child-bearing potential, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist people with Parkinson’s disease by testing the safety and feasibility of using nerve grafts during deep brain stimulation (DBS) surgery. The treatment involves taking tissue from a participant's own nerves, which contains special cells that support brain cells, and implanting it into specific brain areas. This approach might suit someone already planning to undergo DBS surgery and whose Parkinson's responds well to Sinemet, a common medication for the condition. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since participants must show a positive response to Sinemet (carbidopa/levodopa), it seems likely that continuing this medication is required.

What prior data suggests that this method is safe for Parkinson's Disease patients undergoing DBS surgery?

Research has shown that using a person's own nerve tissue for grafts has been studied for safety. In a two-year study, researchers found this procedure safe when combined with deep brain stimulation (DBS) for people with Parkinson's disease. Participants did not experience any major problems related to the nerve grafts.

Another study examined safety over 12 months and confirmed that the procedure was well-tolerated, with no significant safety issues reported.

These studies suggest that using one's own nerve tissue for grafting during DBS surgery is generally safe. However, discussing potential risks with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's Disease?

Unlike the standard treatment options for Parkinson's Disease, which generally include medications like levodopa and surgical procedures such as Deep Brain Stimulation (DBS) alone, the use of autologous peripheral nerve grafts represents a novel approach. This treatment is unique because it involves implanting the patient's own nerve tissue directly into specific areas of the brain affected by Parkinson's. Researchers are excited because this method aims to support and possibly regenerate damaged neural pathways, potentially enhancing the effects of DBS. This innovative approach could lead to improved motor function and quality of life for patients, offering hope for a more effective treatment strategy.

What evidence suggests that this treatment might be an effective treatment for Parkinson's Disease?

Research has shown that using a person's own nerve tissue might be a promising way to treat Parkinson's Disease. In this trial, participants will receive an autologous peripheral nerve graft as part of their treatment. Earlier studies found that recipients of these nerve grafts did not experience worsening in their walking and balance two years after surgery. This suggests the treatment might help maintain movement abilities over time. The grafts use special cells called Schwann cells, which release substances that support brain cells affected by Parkinson's. While researchers continue to gather information, early results suggest these grafts could potentially protect or improve brain function in people with Parkinson's. ^{2 4 5 6 7}

Who Is on the Research Team?

Craig van Horne, MD, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I respond well to Sinemet medication.

I am medically fit for surgery.

I am receiving deep brain stimulation in specific brain areas.

Exclusion Criteria

I am not pregnant, breastfeeding, and if capable of becoming pregnant, I agree to use birth control during the study.

I am not eligible for deep brain stimulation.

I am unable to understand and agree to the study's details on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation

Participants undergo surgical implantation of autologous peripheral nerve graft during DBS surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surgical procedure

15 years

Regular visits as per study protocol

DaTscan Assessment

Dopamine neurodegeneration assessed using DaTscan SPECT imaging

12 or 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Peripheral Nerve Graft

Trial Overview 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.

How Is the Trial Designed?

Group I: Peripheral Nerve Graft Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Craig van Horne, MD, PhD

Lead Sponsor

Trials

5

Recruited

120+

Published Research Related to This Trial

Deep brain stimulation (DBS) is a safe and effective surgical treatment for advanced Parkinson's disease, with a low incidence of serious complications, as shown in a study of 130 patients over several years.

In this study, 62% of patients experienced no complications, and the most common issues were minor, such as aborted procedures (5.14%) and seizures (4.7%), indicating that DBS has a favorable safety profile compared to other surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. Seijo, FJ., Alvarez-Vega, MA., Gutierrez, JC., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01833364

NCT01833364 | Autologous Peripheral Nerve Grafts Into ... By doing this study, the investigators hope to learn provide safety data that can be used to generate a larger phase III clinical trial.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10573749

Recipient Reaction and Composition of Autologous Sural ... We present data from four participants who received autologous transplantation of small pieces of sural nerve tissue into either the basal ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02369003

NCT02369003 | Cont. of a Study to Evaluate Implanting ... This pilot study is designed to follow up on a previous, preliminary study and test the long-term safety and feasibility of the implantation of autologous ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8071359/

Gait and Balance Changes with Investigational Peripheral ... Conclusions: Participants did not show worsening of gait and balance performance in the off therapy state two years after surgery, while the two ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/1877718X241312409

Two-year feasibility and safety of open-label autologous ... Two-year feasibility and safety of open-label autologous peripheral nerve tissue implantation during deep brain stimulation in patients with Parkinson's disease.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27153166/

Implantation of autologous peripheral nerve grafts ... - PubMed The authors have begun an open-label safety study to examine the safety and feasibility of implanting an autologous peripheral nerve graft into ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29451447/

Peripheral nerve grafts implanted into the substantia nigra in ... This study presents a 12-month evaluation of safety and feasibility, as well as the clinical response, of implanting autologous peripheral nerve grafts into ...