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MXN-5 REMOTE

Home-based High Definition Transcranial Electrical Stimulation, without compromise

The Soterix Medical MXN-5 REMOTE is an extension of the groundbreaking mini-CT device into a multi-channel High Definition Transcranial Electrical Stimulation (HD-tES) system. Supervised HD-tES guarantees oversight of the start and completion of every session, ensured by unique MXN-5 Remote features. A system meticulously designed to provide unmatched control and reliability in conducting HD-tES trials in deployed environments without compromising dose precision and safety.

REMOTE session Management, Data Collection, and Adaptive Stimulation
MxN-5 Remote Headgear

Pairing with the ElectraRx portal allows tracking status of remote stimulation sessions anytime and anywhere. Trial administrators can visualize and aggregate individual assessments and correlate outcome progression. Insight from data may be used to adapt stimulation dose on the fly.

In a typical workflow, trial administrators first enter subject information, then assign individual stimulation doses and relevant self-assessments. Subjects access the ElectraRx platform with their unique login to respond to assessments, retrieve stimulation session code, and enter trial-specific information back into the platform.

Soterix Medical REMOTE Neuromodulation systems are governed by three design principles:

Supervised Care

REMOTE Neuromodulation starts and ends with a professional caregiver. Dose control, limits, and remote monitoring are ensured through unique systems and controls.

Right Equipment

Accessories + intelligent hardware equipped with our proprietary LTE technology that are designed for safe and consistent application in deployed environments.

Trial Customizations

Soterix Medical is the technology leader in noninvasive electrical stimulation and has developed advanced task-specific neuromodulation devices.

MXN-5 REMOTE Device Features

Any HD-tDCS, HD-tACS, HD-tRNS, HD-toDCS

Current intensities, durations and repetitions set in each discharge key.

All output performance recorded.

Dose can be adjusted based on patient response.

 MxN 5 Remote Front view

For susceptible subjects, Limited Total Energy minimizes power and energy delivery

Limited Total Energy for tES (LTE-tES) was developed exclusively by Soterix Medical engineers. LTE limits the voltage and power required for tES through the use of adaptive ramp-up stimulation and intelligent energy management.

Full integrated clinical trial support with subject codes and customized sham protocols

Developed to support multi-center clinical trials in HD-tES. Double Blind from Soterix optimizes well beyond traditional ramp up/down shams. For true operator blinding, device operation must balance providing a continuous indication of stimulation and electrode quality status for safety, without betraying whether the stimulation session is real or sham. Since “one size does not fit all,” Soterix Medical scientists work with you to customize Double Blind to your active protocol and electrode montage.

Strict dose limitation

All Soterix Medical REMOTE Neuromodulation systems are equipped with strict dose control features that provide reliable control over the intensity and timing of stimulation. The Dose Limitation feature extends well beyond simple timing control as Soterix Medical considers deploying a device without methods for ongoing monitoring by a professional and methodology to adjust and stop stimulation, not sufficient. Therefore, Dose Limitation technology is integrated with other clinical protocol features and steps unique to each REMOTE Neuromodulation device model. Dose Limitation can be achieved via hardware, software, or wireless supervision. Recognizing that “In Advanced Neuromodulation, One Size Does No Fit All”, Soterix Medical biomedical engineers are ready to customize dose control and compliance approaches to your needs.

Monitoring of dose compliance

Soterix Medical REMOTE Neuromodulation systems are all equipped with unique technology that allows monitoring of dose compliance. This data is collected in a way that is coded to the subject allowing the remote operator to quickly diagnose concerns. If stimulation is aborted or interrupted, impedance is abnormal, or other faults are detected by the device, the system will automatically abort or alter stimulation and the incident details are stored. REMOTE Neuromodulation systems can also be configured to prompt users to survey data. Usage Storage can be achieved through varied combinations of hardware, software, or wireless supervision. Contact Soterix Medical to learn how REMOTE Neuromodulation systems can be programmed to your needs.

A simple feature that minimizes dropout in double-blind clinical trials

Sometimes trivial issues require stimulation interruption or adjustment. Rather than abort a session which can result in subject exclusion or data confounds, the PAUSE feature was developed in collaboration with clinical trial experts running higher-volume or longer duration trials. For both automatic (under SMARTscan™) and user initiated PAUSE, this exclusive feature intelligently avoids breaking sham even in double-blind trials.

Provides a continuous visual indication of electrode quality before and during stimulation

From pre-stimulation set-up, to during stimulation monitoring, to post-stimulation confirmation, the Soterix Medical SMARTscan feature provides an intuitive and clear indication of electrode contact quality. Use SMARTscan during set-up to adjust electrodes and head-gear for optimal fit. During stimulation, SMARTscan provides a constant indication of electrode quality and can be monitored during adjustments. After stimulation, SMARTscan confirms a successful trial. Because “resistance” is not meaningful for HD-tES, SMARTscan was developed by Soterix Medical engineers to provide clinical investigators with a simple to read indication of contact quality.

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Soterix Medical devices provide unique performance as these products, the methods of manufacturing are the subject to one or more U.S. or foreign patients or pending applications including but not limited to US9956395B2, US8818515B2, US8718778B2.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.