Noninvasive Electrosonic Brain Stimulation for Motor, Balance, and Gait Improvement in Parkinson’s Disease

Introduction: Postural instability, gait impairment, and other motor deficits are major contributors to disability in Parkinson’s Disease (PD) and remain insufficiently addressed by pharmacological therapy. This Phase I randomized trial evaluated the safety and efficacy of Electrosonic Stimulation (ESStim), a noninvasive neuromodulation technique combining transcranial ultrasound and transcranial direct current stimulation (tDCS), delivered in conjunction with physical therapy (PT).

Methods: In this double-blind, sham-controlled feasibility trial, 18 PD patients were randomized to Active ESStim (n = 9) or Sham (n = 9). Participants received ten 20-minute stimulation sessions and six PT sessions over two weeks. Follow-up occurred at ~1, 2, 4, and 6 weeks post-treatment. Safety was assessed via adverse event monitoring, EEG, neurological examination, and cognitive testing (SCOPA-Cog, SPMSQ). The primary outcome was change in motor score (UPDRS Part III (UPDRS3)) in the “ON” state. Secondary outcomes included quantitative balance and gait metrics from a motion analysis system, with all assessments conducted in the “ON” state.

Results: No serious adverse events, seizure activity, new neurological signs, or cognitive decline occurred. Minor side effects were transient. Baseline UPDRS3 scores averaged 20.1 with no group difference. At 1-week post-treatment, Active improved 7.6 points vs. 4.3 for Sham (p < 0.05) with benefits sustained to 6 weeks (6.3 vs. 4.3 points; p < 0.05).

Active treatment also produced greater improvements in:
• Postural sway: sway path length -5.0 vs +4.8 cm (p = 0.07, reduction indicates improvement) and mean jerk (p < 0.05).
• Gait performance: 10 m walk time reduction of 1.7 s vs. 0.9 s (p < 0.05) with increased stride length (p < 0.05) and reduced stride count (p < 0.05).

These improvements were measured from the final treatment session through 6-week follow-up.

Conclusion: ESStim combined with PT was safe and produced clinically meaningful, sustained improvements in motor function, balance, and gait in PD. Phase II results are forthcoming.