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