Abstract Details

Although Subthalamic Nucleus (STN) DBS is an established therapeutic option for managing the motor symptoms of PD, a double-blind RCT with sham control had not previously been conducted. We surmise that long-term outcomes (out to 4 years post-implant) in PD patients using an MICC-based DBS device will be similar to or superior than those reported in prior studies.

This is an evaluation of a novel Deep Brain Stimulation (DBS) device capable of Multiple Independent Current Control (MICC) assessed in a prospective, sham-controlled, double-blind randomized controlled trial (RCT) out to 4-year follow-up for treatment of motor symptoms of Parkinson’s disease (PD).

Although Subthalamic Nucleus (STN) DBS is an established therapeutic option for managing the motor symptoms of PD, a double-blind RCT with sham control had not previously been conducted. We surmise that long-term outcomes (out to 4 years post-implant) in PD patients using an MICC-based DBS device will be similar to or superior than those reported in prior studies.

Analysis of the pre-specified primary endpoint demonstrated a mean difference of 3.03 plus/minus 4.52 hours (p less than 0.001) between active and control groups in ON time without troublesome dyskinesia, with no increase in antiparkinsonian medication, from post-implant baseline to 12-weeks post-randomization. At 3-year follow-up, a 46% improvement in UPDRS III scores (n=160) and stable reduction in anti-parkinsonian medication was reported. Eighty-nine percent of patients at 3-year follow-up reported being satisfied/very satisfied/extremely satisfied with their treatment. Four year follow-up data will be presented.

To date, 3-year follow-up results of the INTREPID RCT demonstrate that use of a multiple-source, constant-current DBS system is safe and effective for the long-term treatment of Parkinson’s disease symptoms. Additional follow-up data out to 4 years will be presented.