Session Information
Date: Monday, September 23, 2019
Session Title: Clinical Trials, Pharmacology and Treatment
Session Time: 1:45pm-3:15pm
Location: Agora 3 West, Level 3
Objective: Assess 2-year safety, feasibility, and clinical outcomes of implanting a unilateral peripheral nerve graft to the substantia nigra in patients with Parkinson’s disease at the time of DBS surgery.
Background: After nerve injury, Schwann cells in the peripheral nervous system convert to regeneration-promoting cells – a potential source of neurotrophic and neuroprotective factors. Our strategy is to harness this capacity by delivering autografts of peripheral nerve to the substantia nigra in patients with PD.
Method: Open-label, single center trial with a 2-year follow up every 6 months. Participants received a unilateral autologous peripheral nerve graft (sural nerve) to the substantia nigra at the time they received bilateral DBS to the GPi or STN. Adverse events (AE) were followed and assigned causality. Participants underwent DaTscan™ SPECT imaging, brain MRI scans, and Unified Parkinson ’s Disease Rating Scale scoring.
Results: Of the 18 participants who were assigned to receive the graft, all 18 received the graft at the time of DBS surgery. The most prevalent AE related to the study intervention was paresthesia on the lateral aspect of the foot or ankle. Otherwise, AE profile was comparable to standard DBS. MRI scans 2 years after surgery were unremarkable. Of the 16 (12 male/4 female) who have so far reached the 2-year timepoint, baseline values were: age: 62.9 ± 8.1 (mean ± SD) y, disease duration: 9.3 ± 4.4 y, UPDRS motor scores OFF medication: 37.6 ± 11.1 points. At 2 years, UPDRS Part III scores (OFF medication/OFF stimulation – 12 hours) showed a 25% improvement (-9.6 ± 10.8 points). UPDRS III lateralized scores on the side contralateral to the graft were 5.4 points lower at 2 years than baseline while the side ipsilateral to the graft were 1.2 points lower than at baseline. Contralateral to the graft location, improvements were measured in tremor, bradykinesia, and rigidity components.
Conclusion: We have found unilateral grafting of autologous peripheral nerves to be feasible, safe and suggestive of possible motoric improvement. Additional testing will be needed to confirm these results.
To cite this abstract in AMA style:
C. van Horne, J. Quintero, J. Slevin, J. Gurwell, Z. Guduru, A. Welleford, N. El Seblani, G. Gerhardt. Two-year outcome of autologous peripheral nerve grafting to the substantia nigra at the time of DBS surgery in patients with Parkinson’s disease [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/two-year-outcome-of-autologous-peripheral-nerve-grafting-to-the-substantia-nigra-at-the-time-of-dbs-surgery-in-patients-with-parkinsons-disease/. Accessed November 24, 2024.« Back to 2019 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/two-year-outcome-of-autologous-peripheral-nerve-grafting-to-the-substantia-nigra-at-the-time-of-dbs-surgery-in-patients-with-parkinsons-disease/