Peripheral Nerve Tissue Implantation for Parkinson's Disease (STAR Trial)

Palo Alto (17 mi)

Overseen byCraig G van Horne, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Craig van Horne, MD, PhD

No Placebo Group

Trial Summary

What is the purpose of this trial?The investigators propose a Phase I single surgical-center, double-blinded randomized parallel clinical trial involving bilateral autologous peripheral nerve tissue (PNT) delivery into the NBM or the alternate target also affecting cognition in this population, the substantia nigra (SN), to address "repair cell" support of these areas. Twenty-four participants with idiopathic Parkinson's Disease (PD) who have selected, qualified and agreed to receive as standard of care deep brain stimulation (DBS) will be enrolled and randomly allocated to receive bilateral PNT deployment to either the NBM or SN at the time of DBS surgery. Participants will be allocated equally among both assignments over the course of three years (8 Year 1, 10 Year 2, 6 Year 3). Participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment before surgery, two-weeks after surgery, and 6, 12, and 24 months after surgery.

Eligibility Criteria

This trial is for people with Parkinson's Disease who are already planning to get deep brain stimulation (DBS) surgery. They should be diagnosed with idiopathic Parkinson's and willing to have additional experimental treatment involving their own nerve tissue implanted in the brain.

Inclusion Criteria

I am fit for surgery.

I have been diagnosed with Parkinson's disease.

My sural nerve can be accessed for medical procedures.

I am between 45 and 75 years old.

Exclusion Criteria

I have been diagnosed with dementia.

My brain's pathways to certain areas are not blocked.

I have had surgery for Parkinson's disease or brain surgery.

Treatment Details

The study tests implanting a patient's own peripheral nerve tissue into two different brain areas during DBS surgery. It aims to see if this can help non-motor or motor symptoms of Parkinson’s. Participants will be randomly assigned to receive the tissue in either the NBM or SN area.

2Treatment groups

Active Control

Group I: Peripheral nerve tissue (PNT) deployment to the Substantia NigraActive Control1 Intervention

Group II: Peripheral nerve tissue (PNT) deployment to the nucleus basalis of MeynertActive Control1 Intervention