Impact of Vibration-based Neuromodulation on Freezing of Gait in Parkinson's Disease: A Pilot Study.

BACKGROUND: Freezing of gait (FOG) is an enigmatic phenomenon observed in patients with advanced Parkinson's disease (PD). OBJECTIVES: We present a novel wearable device, Wearable Assisted Locomotor Kinesthesia (WALK), that delivers vibration-based stimulation and test its effectiveness in PD patients with FOG. METHODS: This prospective, nonrandomized, single-center, single-blinded study included 20 PD patients with FOG. Clinical assessments with and without the WALK device were done in the medication OFF state under two conditions: (a) walking and (b) walking + cognitive dual task. A 12-item FOG scale was used to measure FOG across six FOG-provoking tasks. These were assessed at baseline using a placebo device and an active interventional device (WALK). RESULTS: The active device WALK reduced FOG severity by an average of 10.2 points, surpassing the minimal clinically important difference of 4.28 scale points, and participants experienced fewer FOG episodes (a mean of 7.15 fewer episodes). Participants experiencing total akinetic phases (>30s) were able to complete the task with WALK, whereas those receiving a placebo did not. Task completion duration improved by an average of 27.37% across different activities. WALK reduced FOG scores and freezing duration, particularly when navigating through narrow spaces. WALK was also effective in mitigating FOG severity across all Hoehn and Yahr stages. CONCLUSIONS: The WALK device significantly reduced FOG in patients with PD by providing vibration-based stimulation. This noninvasive neuromodulation-based intervention appeared effective and safe in this pilot study, with no adverse events, highlighting its potential in the management of FOG.