Phase I Study on Safety and Feasibility of Implanting Your Own Sural Nerve Tissue into the Brain for Parkinsons Disease or Multiple System Atrophy

What this Trial Is About

Researchers are evaluating the safety and feasibility of implanting a persons own peripheral nerve tissue into the substantia nigra area of the brain in people diagnosed with Parkinsons disease or Multiple System Atrophy. This phase I study involves 7 participants who are early in their diagnosis with milder symptoms. The goal is to plan future larger trials and to see if this nerve tissue grafting approach is possible and safe. Participants will be randomly assigned to one of two groups four will receive the nerve tissue graft implanted into the brain, while three will receive a sham surgery involving nerve biopsy and scalp incisions but no brain implantation. The nerve tissue is taken from the sural nerve near the ankle and implanted bilaterally using a specialized cannula through the skull. Those in the sham group may be eligible for the graft surgery after the study ends. During the study, participants will be followed for one year with regular assessments including neuropsychological exams, movement disorder scales, cognitive tests, quality of life questionnaires, and monitoring for adverse events. Researchers will track surgery details such as procedure duration and hospital stay. The primary goal is to meet recruitment targets and evaluate safety and feasibility through various clinical and functional measures over the 12-month period.

Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies