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

70 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Autologous Peripheral Nerve Graft for Parkinson's Disease?

Research shows that implanting autologous peripheral nerve grafts during deep brain stimulation surgery is safe and may improve motor function in Parkinson's patients, as seen in improved motor scores after 12 months. Additionally, the grafts encourage growth of nerve fibers, which could help restore brain function. ^{1 2 3 4 5}

Is the combination of nerve grafts and DBS surgery safe for humans?

The combination of nerve grafts and DBS surgery for Parkinson's disease has been studied for safety, showing that adverse events were similar to standard DBS surgery. Some participants experienced numbness at the nerve harvest site, and one had a minor infection, but no severe complications were reported. ^{1 2 3 4 6}

How does the nerve grafts and DBS surgery treatment for Parkinson's disease differ from other treatments?

This treatment is unique because it combines deep brain stimulation (DBS) with the implantation of autologous peripheral nerve grafts, which are taken from the patient's own body and contain Schwann cells that provide neurotrophic factors to potentially restore nerve function. Unlike standard treatments, this approach aims to deliver neurorestorative therapy directly to the brain, which may help improve symptoms and slow disease progression. ^{1 2 3 5 7}

What is the purpose of this trial?

This trial tests the safety of implanting a patient's own nerve tissue into their brain during surgery for Parkinson's disease. The goal is to use natural substances from the nerve tissue to help protect and repair brain cells affected by the disease.

Research Team

Craig van Horne, MD, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Peripheral nerve grafts implanted into the substantia nigra in patients with Parkinson's disease during deep brain stimulation surgery: 1-year follow-up study of safety, feasibility, and clinical outcome. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Gait and Balance Changes with Investigational Peripheral Nerve Cell Therapy during Deep Brain Stimulation in People with Parkinson's Disease. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Implantation of autologous peripheral nerve grafts into the substantia nigra of subjects with idiopathic Parkinson's disease treated with bilateral STN DBS: a report of safety and feasibility. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Recipient Reaction and Composition of Autologous Sural Nerve Tissue Grafts into the Human Brain. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Fetal mesencephalic neurons survive and extend long axons across peripheral nervous system grafts inserted into the adult rat striatum. [2019]

6. Austria pubmed.ncbi.nlm.nih.gov

Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Two-year follow-up study of a patient with Parkinson's disease and severe motor fluctuations treated by co-grafts of adrenal medulla and peripheral nerve into bilateral caudate nuclei: case report. [2019]