Square Biphasic Pulse Deep Brain Stimulation for Parkinson’s Disease: The BiP-PD Study

BACKGROUND: Conventional Parkinson’s disease (PD) deep brain stimulation (DBS) utilizes a pulse with an active phase and a passive charge-balancing phase. A pulse-shaping strategy that eliminates the passive phase may be a promising approach to addressing movement disorders. OBJECTIVES: The current study assessed the safety and tolerability of square biphasic pulse shaping (sqBIP) DBS for use in PD. METHODS: This small pilot safety and tolerability study compared sqBiP versus conventional DBS. Nine were enrolled. The safety and tolerability were assessed over a 3-h period on sqBiP. Friedman’s test compared blinded assessments at baseline, washout, and 30 min, 1 h, 2 h, and 3 h post sqBIP. RESULTS: Biphasic pulses were safe and well tolerated by all participants. SqBiP performed as well as conventional DBS without significant differences in motor scores nor accelerometer or gait measures. CONCLUSION: Biphasic pulses were well-tolerated and provided similar benefit to conventional DBS. Further studies should address effectiveness of sqBIP in select PD patients.