Asymmetric STN DBS for FOG in Parkinson's disease: A pilot trial

Background In Parkinson's disease (PD), freezing of gait (FOG) is a highly disabling gait disorder. Though deep brain stimulation (DBS) of the subthalamic nucleus (STN) is an efficient treatment for advanced PD, the management of STN DBS refractory FOG remains challenging. Objective To evaluate the long-term impact on FOG of unilateral stimulation reduction in PD treated with bilateral STN DBS. Methods Patients with bilateral STN DBS for at least one year and refractory FOG were included in a randomized, double blind, cross-over clinical trial. They were randomized to chronic (CHR) vs. experimental (EXP) stimulation (30% amplitude reduction contralateral to the least affected body side), each condition for 4 weeks. Gait and FOG were assessed both in the OFF and ON medication conditions. Primary outcome was the difference in the FOG percentage during gait assessment and in a composite gait score in CHR vs. EXP stimulation. Results The study was stopped early for futility. Of the 12 patients included, eight dropped out because of re-emerging of PD symptoms. In the four patients who sustained the experimental condition, the FOG percentage did not improve, whether in the OFF (CHR: 13.4% vs. EXP: 16.8%) or in the ON (CHR: 19.5% vs. EXP: 19.8%) medication condition. There was no change in the composite gait score (CHR: 5.5 ± 1.3 vs. EXP: 6.3 ± 3.3). Conclusions Most patients did not tolerate the unilateral amplitude reduction of STN DBS in the long-term. Moreover, this strategy failed to improve FOG in patients who could sustain the procedure. Clinicaltrial.gov identifier NCT02704195.