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mini-CT

SNAP Headgear

ElectraRx
ResearchREMOTE

Remote Neuromodulation

Deployed transcranial electrical stimulation, without compromise.

Soterix Medical REMOTE Neuromodulation is the only system with device, accessories, and software designed for deployed use. Safe transcranial Electrical Stimulation requires advanced systems designed for consistency and control. REMOTE Neuromodulation is the only system designed from the ground up to allow translation of clinical tES, including tDCS protocols, to diverse deployed environments, while maintaining medical standards.

mini-CT device

Fail-safe and intelligent hand-held stimulators designed specifically for deployed use. Deliver only the right dose at the right time, with onboard compliance recording and ElectraRx compatibility Learn more...

SNAP Headgear accessories

The only head-gear that is simple to self-apply and guarantees accurate electrode placement. The only pre-saturated snap electrodes for tES in deployed environments
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ElectraRx software

ElectraRx integrates complete screening and assessments, tDCS dose management, and online digital therapeutics all in one place that can be accessed from anywhere
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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.

Soterix Medical REMOTE
Neuromodulation systems are uniquely validated

Soterix Medical hardware and accessories for remote use are the only equipment designed and validated for that purpose. Other systems designed for use by professionals and medical and research centers cannot be rigged for home use.

Soterix Medical REMOTE is supported by over a dozen clinical trials including the demonstration of tolerability, reproducibility, and compliance.

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Soterix Medical Case Use 2

Rigorous Remotely Supervised Home Delivery in Multiple Sclerosis.

Soterix Medical Case Use reports are provided for information purpose only and the original publications should be consulted for comprehensive details.

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

1

Concept and Guidance:

A multi-disciplinary team of scientists and Soterix Medical engineers develop the first systematic guidance for tDCS delivery, away at home. The guidance emphasizing the rigor of this approach is called: Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials - guidelines for technology and protocols. Recommendations include methods for training, ongoing assessment, and use of only devices and accessories explicitly designed for remote use – including the Soterix Medical REMOTE platform.

  • Remotely-supervised tDCS for clinical trials: guidelines for technology and protocols Charvet L, Kasschau M, Datta A, Knotkova H, Stevens M, Alonzo A, Loo C, Krull K, Bikson M. Front. Syst. Neurosci, 17 March 2015

    • 2

    Planning and Design:

    Trial specific protocols are established for Remotely-Supervised tDCS in Multiple Sclerosis (MS). Home-use tDCS protocol, device, and accessories must be customized with special consideration for the patient population. As part of rigorous operator training, instructional videos are developed. From recruitment, to inclusion/exclusion, use of secure video conference software, to the custom head-gear and patient “tool-box”, Soterix Medical engineers worked closely with clinicians to develop a reproducible and tolerated protocol.

  • A Protocol for the Use of Remotely-Supervised tDCS in Multiple Sclerosis. Kasschau M, Sherman K, Haider L, Frontario A, Shaw M, Datta A, Bikson M, Charvet L. J Vis Exp. Dec 26 2015

    • 3

    Validation:

    A rigorous compliance and tolerability trial is conducted. To provide accessible treatment while maintaining clinical trial standards for study in MS, clinical investigators worked with Soterix Medical engineers to develop a remotely supervised tDCS protocol. A telemedicine protocol with remotely delivered tDCS removes logistical barriers limiting MS patient access to ongoing treatment without compromising tDCS quality. The use of Soterix Medical REMOTE tDCS hardware and accessories is validated in a target patient population.

  • tDCS Is Feasible for Remotely Supervised Home Delivery in Multiple Sclerosis. Kasschau M, Reisner J, Sherman K, Bikson M, Datta A, Charvet LE. Neuromodulation. Apr 18 2016

    • Soterix Medical was founded to support the rigorous science and medicine of non-invasive neuromodulation

    Supervised Neuromodulation

    The administrator programs their desired stimulation settings in the password-protected ‘Administration’ section of the device and generates up to 400 single-use stimulation session codes.

    The administrator uploads the stimulation session codes to the ElectraRx portal, assigns the device to a patient/subject, sets a treatment schedule, and assigns pre and post-stimulation assessments.

    The patient/subject is provided with the device, a SNAPstrap, and a sufficient number of SNAPpads to complete treatment.

    The administrator provides in-person or video-supervised training to the patient/subject to ensure proper set-up and positioning of the electrodes.

    When the patient/subject is ready to start a remote session, they log in to the ElectraRx portal on their assigned treatment days to complete assessments and obtain a single-use stimulation session code.

    The patient/subject selects ‘Stimulation’ from the device menu, ensures proper contact quality of the electrodes, and inputs the code to start the stimulation session.

    Upon completion of a session, the patient/subject retrieves a completion code from the device and enters it in the ElectraRx portal.

    The administrator can log in to their ElectraRx account to view the session history and confirm session completion.

    Exclusive Soterix Medical Remote System Features

    Each Soterix Medical feature was developed by our team of biomedical engineers consulting closely with leading clinical centers. Designed to simply set-up, provide intelligent warning of a fault condition, and allow for adjusting for patient comfort, these features facilitate reliable and tolerated tES. The Soterix Medical SMARTscan™ feature is central in all neuromodulation devices to allow reliable set-up and monitoring.

    Any tDCS, tACS, tRNS, toDCS

    Current intensities, durations and repetitions set in each discharge key. All output performance recorded. Dose can be adjusted based on patient response.

    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.

    For reproducible neuromodulation, 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 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.

    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 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.

    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 (e.g. addition of saline to drying electrodes). After stimulation, SMARTscan™ confirms a successful trial. Because “resistance” is not meaningful for tES, SMARTscan™ was developed by Soterix Medical engineers to provide clinical investigators with a simple to read indication of contact quality.

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