Abstract Details

Subthalamic Nucleus (STN) DBS is an established therapeutic option for managing motor symptoms of PD. Here we report long-term outcomes (up to 5-years) of an ongoing study using an MICC- based DBS device.

INTREPID (Clinicaltrials.gov: NCT01839396) is a multi-center, prospective, double-blinded randomized control trial (RCT). Subjects were implanted bilaterally in the STN with a multiple-source, constant-current DBS system (Vercise, Boston Scientific). Subjects were randomized to either receive active versus sham control settings for 12 weeks. Upon completion of the 12- week blinded period, subjects received their best therapeutic settings in the open-label phase of the trial. During long-term follow- up, motor improvement and quality of life was evaluated using UPRDS, PDQ-39, and Global Impression of Change. Anti-parkinsonian medication and adverse events were also collected.

The pre-specified primary endpoint, assessed from post-implant baseline to 12-weeks was met on the basis of improvement in ON time without troublesome dyskinesias and no change in anti-parkinsonian medications (Vitek JL., et al. Lancet Neurol. 2020). At the end of the blinded phase, ON time without troublesome dyskinesias increased by 5.6 ± 4.6 hours in the active group vs. 1.66 ± 3.7 hours in the control group. At 4-year follow-up, a 41% improvement in UPDRS III scores (stim on/meds off) was reported compared with screening. Anti-parkinsonian medication reduction remained stable with sustained improvement in Quality-of-Life and treatment satisfaction.

Long-term follow-up from the INTREPID RCT demonstrates that the use of a multiple-source, constant-current DBS system is safe and effective with sustained improvement in motor function and quality of life in PD patients.