Worldwide

mini-CT

The device that defined the supervised neuromodulation class.


The Soterix Medical mini-CT captures the features of the clinical trial standard 1x1-CT in a deployable platform. Supervised neuromodulation guarantees over site at the start and completion of every session, ensured by unique mini-CT features. Two models, the 1x1 tDCS mini-CT and the 1x1 tES mini-CT, provide unmatched controlled and reliability in conducting tDCS or tES trials in deployed environments without compromising dose precision and safety.

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. *

*Soterix Medical does not provide consulting or support on technologies, including electrodes and dose guidelines, not produced or explicitly endorsed for compatibility by Soterix Medical or our authorized distributors. For concerns not using the mini-CT or other approved Soterix Medical platforms and accessories, please contact your vendor directly.

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

One validated system, two device models

1x1 tES mini-CT

  • Remote supervised delivery of tDCS, tACS, tRNS, or tPCS
  • tES-LTE enabled
  • Simple interface
  • Customized accessories
  • Very compact design
  • Secure administrator mode to program sessions
  • Storage: 1800 Session
  • Intelligent power management to maximize battery life
  • Power: one internal rechargable battery
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1x1 tDCS mini-CT

  • Cost effective device for remote supervised tDCS
  • tDCS-LTE enabled
  • Simple interface
  • Customized accessories
  • Compact design
  • Secure administrator mode to program sessions
  • Storage: 250 sessions
  • Intelligent power management to maximize battery life
  • Power: one 9v Battery
Manual & Specifications

mini-CT Device Features

Each Soterix Medical 1×1 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 REMOTE Neuromodulation. The Soterix Medical SmartScan™ feature is central in all REMOTE 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.

tDCS

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

Software (code) based dose limitation

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

Limited Total Energy for tDCS (LTE-tDCS) was developed exclusively by Soterix engineers. LTE limits the voltage and power required for tDCS 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 tDCS. Double Blind from Soterix optimize 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 you active protocol and electrode montage.

Software (code) based usage storage

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 tDCS, 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.

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

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