Complete-Loop Electronic Stimulation (ES) - Mechanomyogram Sensor (MMG) System for Passive Tremor Suppression Treatment

Background/Need Pathological tremor is the most common movement disorder worldwide, impacting a staggering 5-11% of people over 60 [1]. Treatment options centre on pharmaceuticals and/or surgery; both have limited efficacy and harmful side-effects [2,3] . Furthermore, many patients do not receive appropriate treatment (e.g. 80% of essential tremor patients [3]).

Proposed Resolution We introduce a wearable tremor suppression system combining our work in: Low-level Electrical Stimulation (ES): We pioneered the first imperceptible (sub-motor-threshold) ES tremor suppression system. Our clinical testing proved low-level ES suppresses tremor symptomatically [4,5].

Furthermore, we conducted a 9-patient trial [10] showing prolonged tremor reduction using our neuro-stimulation system.

Mechanomyography (MMG) closed-loop feedback: We developed [6,7] and patented [9], a novel MMG sensor, the first demonstrated to map muscle activity during tremor [8]. MMG allows closed-loop optimisation of muscle response during ES (impossible with existing EMG).

We propose a 24-month program to prototype an 'ES-MMG' wearable tremor treatment system and clinically demonstrate its veracity.

Research Questions This program will answer: Is ES-MMG a viable, zero side-effect alternative (even augmentation) to expensive/invasive tremor treatments (pharmacotherapy, botulinum toxin, surgery, etc.)?

Does regular ES-MMG tremor treatment reduce the frequency and magnitude of tremor (i.e. produce a patient-specific therapeutic outcome)? Will patients and clinicians comply with use of ES-MMG treatment if packaged as a simple wearable?

Aims/Objectives Integration of ES system with closed-loop MMG feedback for sustained tremor suppression Development of patient-specific therapeutic treatment Understanding longitudinal impact of therapeutic treatment to condition and quality-of-life Commercialisation validation, including Independent Health Economic justification Methods/Timelines 24-months, starting 01/03/2021 Prototype Development (12-months): fabricate wearable ES-MMG system 10-Patient Validation Study (1-month): further patient feedback/refinement 20-Patient Longitudinal Study (5-months): placebo-methodology End-to-End Product Refinement/Commercial Validation (6-months): wearable packaging; patient/clinician app development Expected Outcomes 20 patient longitudinal-treatment validation Prototype for subsequent clinical trials Commercial funding secured from feasibility demonstration