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Led by Craig van Horne, MD, PhD · Updated on 2025-08-14
24
Participants Needed
1
Research Sites
60 weeks
Total Duration
Researchers are investigating the safety, feasibility, and clinical effects of implanting autologous peripheral nerve tissue PNT into specific brain areas to support motor and non-motor symptoms in patients with Parkinsons Disease PD undergoing deep brain stimulation DBS surgery. This Phase I randomized, double-blind trial focuses on comparing PNT delivery to either the nucleus basalis of Meynert NBM or the substantia nigra SN, both important brain regions involved in cognitive and motor functions. The study enrolls 24 participants over three years to evaluate this repair cell approach in PD treatment. Participants will undergo standard DBS surgery, during which a sural nerve biopsy is taken from the ankle. Small pieces of the processed nerve tissue are then implanted bilaterally into either the NBM or SN based on random assignment. The trial monitors the surgical delivery of PNT and compares the outcomes between the two brain target groups. This procedure aims to assess the effects of PNT on brain areas affecting cognition and motor symptoms in PD. Participants will be assessed before surgery, two weeks after, and at 6, 12, and 24 months post-surgery for neurocognitive function, motor abilities, daily living activities, and quality of life. Researchers will track successful PNT implantation, study-related adverse events, and changes in cognitive and motor scales such as the Montreal Cognitive Assessment MoCA and Movement Disorder Society Unified Parkinsons Disease Rating Scale MDS-UPDRS. The study includes long-term follow-up to evaluate safety and clinical responses over two years after surgery.
CONDITIONS
A Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Brain for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery
J
Jaimie Hixson
G
Group Monitored Email
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Craig van Horne, MD, PhD
Lead Sponsor
National Institute on Aging (NIA)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Peripheral Nerve Tissue to Substantia Nigra | Peripheral Nerve Tissue to Nucleus Basalis of Meynert |
|---|---|---|
| What it is | Implantation of a patient's own peripheral nerve tissue into the substantia nigra region of the brain during standard deep brain stimulation (DBS) surgery. | Implantation of a patient's own peripheral nerve tissue into the nucleus basalis of Meynert during standard DBS surgery. |
| Role in the trial | Participants assigned to this group receive PNT into the substantia nigra and are monitored for safety and clinical response after DBS. | Participants assigned to this group receive PNT into the nucleus basalis of Meynert and are monitored for safety and clinical response after DBS. |
| Primary use or study aim | To evaluate if PNT implantation into the substantia nigra during DBS surgery is feasible, safe, and can affect motor and non-motor symptoms in Parkinson's disease. | To evaluate if PNT implantation into the nucleus basalis of Meynert during DBS surgery is feasible, safe, and can affect cognitive and non-motor symptoms in Parkinson's disease. |
| How it is given or performed | During DBS surgery, surgeons harvest peripheral nerve tissue from the patient’s ankle (sural nerve), then implant it into the substantia nigra of both sides of the brain in small pieces, after preparing the tissue in the operating room. | During DBS surgery, surgeons harvest sural nerve tissue and implant it into the nucleus basalis of Meynert on both sides of the brain, following in-operating-room preparation similar to the other group. |
| Evidence status | No definitive efficacy data yet. Prior open-label and feasibility studies have shown the procedure is technically feasible and generally well tolerated; controlled evidence of clinical benefit is still limited, and this randomized study is ongoing. | There is no established benefit as of now; prior open-label experience with PNT to the NBM is limited. This randomized study seeks to clarify any cognitive or non-motor effects. |
| Important limitations | Current evidence comes mainly from small feasibility or open-label studies. Long-term outcomes and potential benefit on symptoms are not yet established. Risks relate to surgical intervention and tissue harvesting. | Findings are limited by small cohort sizes, lack of established efficacy, and absence of long-term data so far for the NBM as an implantation site. Procedure risks also relate to both brain implantation and nerve harvesting. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo deep brain stimulation (DBS) surgery during which a biopsy of the sural nerve is taken and autologous peripheral nerve tissue is implanted bilaterally into the brain.
1 surgical visit (in-person)
Duration - Up to 24 months
Participants are monitored with clinical assessments to evaluate safety and clinical responses after the surgery and implantation.
Visits at 6, 12, and 24 months for clinical assessments
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Jorge E Quintero, Monica J Chau, John T Slevin...
https://pubmed.ncbi.nlm.nih.gov/40007169/Jorge E Quintero, John T Slevin, Julie A Gurwell...
https://pubmed.ncbi.nlm.nih.gov/35949912/Craig G van Horne, Jorge E Quintero, John T Slevin...
https://pubmed.ncbi.nlm.nih.gov/29451447/Craig van Horne, MD, PhD
Lead Sponsor
National Institute on Aging (NIA)
Collaborating Sponsor
