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

Launched by CRAIG VAN HORNE, MD, PHD · Nov 8, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for people with Parkinson's disease or Multiple System Atrophy, which are conditions that affect movement and can cause various symptoms. The study aims to see if implanting a small piece of nerve tissue from the patient’s own body into a specific area of the brain (called the substantia nigra) is safe and feasible. In this trial, seven participants will be involved, with four receiving the nerve graft and three undergoing a sham surgery, which means they will not receive the actual treatment. Participants will be closely monitored for one year after the surgery.

To be eligible for this trial, participants need to be between 40 and 75 years old and have been diagnosed with Parkinson's disease or Multiple System Atrophy for more than two years. They should also have a certain level of symptoms measured by a specific scale, and they must be able to undergo some tests and the surgical procedure. It's important to note that individuals who have had previous brain surgery or have specific medical conditions may not be eligible. This trial is currently recruiting participants, and it offers a potential new avenue for treatment in the early stages of these diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of clinically established or clinically probable PD or MSA as defined by MDS criteria
• • Disease duration greater than 2 years
• • Age 40-75, inclusive
• • MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III greater than or equal to 20 points but less than or equal to 35 points, off anti-parkinsonian medication for PD or MDS-Unified Multiple System Atrophy Rating Scale (UMSARS) less than or equal to 30 points off anti-parkinsonian medication
• • No MDS-UPDRS Part III score \>3 on items 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.14 while off medication
• • Able and willing to undergo ioflupane/SPECT
• • Able to tolerate the surgical procedure
• • Able to undergo all planned assessments
• • Available access to the sural nerve
• Exclusion Criteria:
• • Previous PD surgery or intracranial surgery
• • Ongoing major medical or psychiatric disorder incl. depression and psychosis
• • Other concomitant treatment with neuroleptics
• • Typical, nonparkinsonian syndrome ioflupane/SPECT signal
• • Unable to undergo an MRI
• • An obstructed trajectory path to the substantia nigra
• • Significant microvascular disease
• • Use of anticoagulants other than aspirin
• • Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study
• • Consent capacity will be assessed and determined during and throughout a participant's neuropsychological exam. A participant who experiences a decline in consent capacity prior to surgery, will be removed from the study by the PI. A decline in consent capacity after surgery will not result in the removal of the participant in the study.