Long-term safety and efficacy of frameless subthalamic deep brain stimulation in Parkinson’s disease

Abstract

Background Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) is standard of care for Parkinson’s disease (PD) patients and a correct lead placement is crucial to obtain good clinical outcomes. Evidence demonstrating the targeting accuracy of the frameless technique for DBS, along with the advantages for patients and clinicians, is solid, while data reporting long-term clinical outcomes for PD patients are still lacking. Objectives The study aims to assess the clinical safety and efficacy of frameless bilateral STN-DBS in PD patients at 5 years from surgery. Methods Consecutive PD patients undergoing bilateral STN-DBS with a frameless system were included in this single-center retrospective study. Clinical features, including the Unified Parkinson’s Disease Rating Scale (UPDRS) in its total motor score and axial sub-scores, and pharmacological regimen were assessed at baseline, 1 year, 3 years, and 5 years after surgery. The adverse events related to the procedure, stimulation, or the presence of the hardware were systematically collected. Results Forty-one PD patients undergone bilateral STN-DBS implantation were included in the study and fifteen patients already completed the 5-year observation. No complications occurred during surgery and the perioperative phase, and no unexpected serious adverse event occurred during the entire follow-up period. At 5 years from surgery, there was a sustained motor efficacy of STN stimulation: STN-DBS significantly improved the off-stim UPDRS III score at 5 years by 37.6% (P < 0.001), while the dopaminergic medications remained significantly reduced compared to baseline (− 21.6% versus baseline LEDD; P = 0.036). Conclusions Our data support the use of the frameless system for STN-DBS in PD patients, as a safe and well-tolerated technique, with long-term clinical benefits and persistent motor efficacy at 5 years from the surgery.

Effectiveness and reliability of hypnosis in stereotaxy: a randomized study

“…However, nerve blocks were less painful than subcutaneous LA at both the frontal (VAS, 34 ± 24 vs 49 ± 25) and occipital (VAS, 34 ± 21 vs 49 ± 23) sites. Aside from pain-reduction procedures, frameless stereotactic interventions [ 24 , 53 ] have been promoted recently, as have been fully asleep DBS surgeries [ 6 , 9 , 18 , 32 ]…”

Demographics of focused ultrasound thalamotomy for essential tremor and trends in deep brain stimulation surgery after its introduction in the USA

“…30 Emergent evidence demonstrating the efficacy and safety of DBS, and greater patient and provider confidence in the procedure may also be a significant reason for the increase in DBS procedures since 2016. [31][32][33] It is also important to note that our analysis does not control for the difference in the frequency of ET diagnoses before and after 2016.…”