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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

Study acronym: STAR
StatusRecruiting
PhasePhase 1
Started2025-07-21
View on ClinicalTrials.gov ↗
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.

Amendment history 2 changes detected by DataLookout

2026-09-01
critical
Primary completion pushed: 2026-12-31 → 2028-12-31
2026-09-01
minor
Completion pushed: 2028-02-28 → 2030-05-28
Trial Details
NCT Number NCT06683378
Lead Sponsor Craig van Horne, MD, PhD
Collaborators: National Institute on Aging (NIA)
Conditions Parkinson's Disease
Enrollment 24 participants
Start Date 2025-07-21
Primary Completion 2028-12-31 (estimated)
Study Completion 2030-05-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-31