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 environment.
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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 thought 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 environment.

Trial customization

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 is the only equipment designed and validated for the purpose. Other systems designed for use by professional 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.

Soterix Medical Case Use

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 the 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 llogistical barriers limiting MS patient access to ongoing treatment without comprising 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

    This schematic illustrates the principle of supervised neuromodulation. While not intended to capture the details of device and headgear design (which are customized for each use), or the trial specific technology of telemedicine (including use of text or video conferencing), the principle or supervision at the start and completion of each trial is highlighted. Without compliance and control, remote use of neuromodulation will not meet medical standards.

    Users are provided with an individual device and accessories such as the 5x-Session Home Kit. The subject checks in with the supervisor before and after each session. The supervisor unlocks operation before each session by providing a code. The subject enters only the code being providing no access to device programming or stimulation settings. The subject used custom fit headgear to position electrodes. The device automatically collected compliance data and may also prompt the user for information. Details of implementation will be customized to each clinical trial while maintaining the principles of supervised neuromodulation. Soterix Medical expert support is ready to work with you to optimize trial design

    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 feature that provide reliable control over the intensity and timing of stimulation. The Dose Limitation feature extends well beyond simple timing control as Soterix Medical consider 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 susceptible subjects, Limited Total Energy minimize 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 for currents up to 1.5 mA.

    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 the 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.