Objective: The ClearPoint real-time interventional MRI-guided methodology for deep brain stimulation (DBS) lead placement may offer advantages to frame-based approaches and allow accurate implantation under general anesthesia. In this study, the authors assessed the safety and efficacy of DBS in Parkinson's disease (PD) using this surgical method.
Methods: This was a prospective single-center study of bilateral DBS therapy in patients with advanced PD and motor fluctuations. Symptom severity was evaluated at baseline and 12 months postimplantation using the change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III "off" medication score as the primary outcome variable.
Results: Twenty-six PD patients (15 men and 11 women) were enrolled from 2010 to 2013. Twenty patients were followed for 12 months (16 with a subthalamic nucleus target and 4 with an internal globus pallidus target). The mean UPDRS Part III "off" medication score improved from 40.75 ± 10.9 to 24.35 ± 8.8 (p = 0.001). "On" medication time without troublesome dyskinesia increased 5.2 ± 2.6 hours per day (p = 0.0002). UPDRS Parts II and IV, total UPDRS score, and dyskinesia rating scale "on" medication scores also significantly improved (p < 0.01). The mean levodopa equivalent daily dose decreased from 1072.5 ± 392 mg to 828.25 ± 492 mg (p = 0.046). No significant cognitive or mood declines were observed. A single brain penetration was used for placement of all leads, and the mean targeting error was 0.6 ± 0.3 mm. There were 3 serious adverse events (1 DBS hardware-related infection, 1 lead fracture, and 1 unrelated death).
Conclusions: DBS leads placed using the ClearPoint interventional real-time MRI-guided method resulted in highly accurate lead placement and outcomes comparable to those seen with frame-based approaches.
Trial registration: ClinicalTrials.gov NCT00792532.
Keywords: AP = anteroposterior; CGI = Clinical Global Impression; ClearPoint; DBS = deep brain stimulation; GPi = internal globus pallidus; IPG = implantable pulse generator; LEDD = levodopa equivalent daily dose; MER = microelectrode recording; PD = Parkinson’s disease; PDQ-39 = Parkinson’s Disease Questionnaire-39; Parkinson’s disease; SF-36 = 36-Item Short Form Health Survey; STN = subthalamic nucleus; UPDRS = Unified Parkinson’s Disease Rating Scale; deep brain stimulation; functional neurosurgery; iMRI = interventional MRI; interventional MRI; outcomes.