Clinical outcomes using ClearPoint interventional MRI for deep brain stimulation lead placement in Parkinson’s disease

Abstract

(DBS) has been shown to be a highly effective treatment option for medicationrefractory Parkinson's disease (PD) patients experiencing motor fluctuations and dyskinesia. 5,15,18,21,22,26,31 Clinical outcomes with DBS are critically dependent on the exact lead placement in the intended brain target (dorsal lateral subthalamic nucleus [STN] or posterior [motor] area of the internal globus pallidus [GPi]), but surgical methods to achieve acceptable placement are not standardized. The traditional method for DBS lead implantation involves the use of preoperative brain images registered in a stereotactic coordinate system, and physiological localization using microelectrode-guided mapping of the target regions while patients are awake.28 This method poses challenges when patients are not able to tolerate and/or cooperate with awake surgery (severe "off" medication symptoms, anxiety, pain).Recently a new method has been developed for implan- 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.Clinical trial registration no.: NCT00792532 (clinicaltrials.gov)

A novel re-attachable stereotactic frame for MRI-guided neuronavigation and its validation in a large animal and human cadaver model

“…As an alternative to frame-based stereotactic systems, frameless technologies continue to emerge, although there is debate regarding their ease-of-use and accuracy compared to conventional stereotactic frame-based approaches (Machado et al 2006, Starr et al 2010, Mirzadeh et al 2014, Chabardes et al 2015, Ostrem et al 2016). One such system is the Nexframe™ stereotactic system, which uses implanted skull fiducials and leverages intraoperative neuroimaging technologies to achieve 3D spatial accuracy comparable to conventional frame-based approaches (Bot et al 2015).…”

Deep Brain Stimulation: Awake and Asleep Options

“…[23][24][25] The outcomes in patients undergoing "asleep" DBS has certainly been comparable, with patients experiencing a 40-66% improvement in UPDRS-III motor scores after 6 months. 15,26,27 Similarly, 41 patients who underwent "asleep" STN DBS continued to demonstrate significant reduction of motor fluctuations, dyskinesias, and demands in dopaminergic medications at 5 years after implantation; however axial symptoms and bradykinesia continued to worsen as part of disease progression. 28 A direct comparison between the two approaches was performed by Saleh et al, who performed a retrospective review in which they compared 14 patients who underwent DBS placement under general anesthesia to 23 patients who underwent DBS placement while awake with MER.…”

“…The main premise of this approach is that MRI technology is now capable of clearly identifying the anatomy of the deep brain target; and that intraoperative imaging can be used to verify the location of the DBS lead in this target. As such, both MRI [11][12][13] and CT [14][15][16][17] placement of a stereotactic (Leksell) frame under local anesthesia. After a reference CT is acquired with the frame on the patient, this image is merged with the MRI containing the stereotactic plan.…”

“…19,35,36 In addition, since no intraoperative neurophysiologic or clinical testing is being performed there is no need to force the patient to an OFF-state; and the lack of complete levodopa reduces tremor severity, painful "off" dystonia or rigidity, "off" anxiety, and confusion for the patient. 19,27,35,36 The result of all of these factors is more rapid mobilization after surgery and a overall shorter recovery period. Lastly, although more difficult to interpret than in awake patients, MERs can even be performed during "asleep" surgery and has been reported by a few institutions.…”

Hemorrhage Detection and Incidence during Magnetic Resonance-Guided Deep Brain Stimulator Implantations

“…An advantage of the technique is that patients are anesthetized and surgery is shorter than conventional implantation approaches that rely on intraoperative physiological assessments. Electrode placement is accomplished in the overwhelming majority of cases with a single brain penetration and excellent anatomical targeting accuracy has been achieved [7,9,10,11]. …”