Soterix Medical Inc.announces today the launch of its new mini-CT platform for remote-supervised noninvasive neuromodulation for transcranial Direct Current Stimulation (tDCS). The mini-CT represents a fundamental technological advance toward future home treatment with Electroceuticals by providing clinical researchers the first device, headgear, and electrodes for reproducible stimulation away form the clinic. The device will be validated through a series of clinical trials including for Multiple Sclerosis, ADHD, cancer-treatment related Cognitive Morbidities in adults and children, Migraine, and Palliative Pain Management with additional trials pending. The mini-CT device is available immediately for clinical trials. Initial clinical trials will also validate whether tDCS can be applied remotely but under strict clinical supervision without compromising tolerability or reproducibility.
Soterix Medical, Inc. (SMI) is the recognized leader in non-invasive neuromodulation with low-intensity stimulation and the release of mini-CT further underlines the company’s mission to advance the science of neuromodulation by providing the most advanced and rigorous technology. The mini-CT includes many proprietary technologies developed by Soterix Medical including Limited Total Energy (LTE), protocols for double blind clinical trials adapted from the 1x1-CT line (being used in all major multi-center tDCS trials), and several further innovations specific to remote supervised use. The use of LTE is especially critical under deployed environment and allows the device to automatically detect and correct for non-optimal conditions. These unique innovations include a singe-snap version of the Soterix Medical EASYstrap, which ensures consistent and reproducible electrode placement. The devices use a novel form of dose compliance control where the system cannot be activated until a single-use code is provided by the supervisor and the device recognizes proper configuration. The codes are unique and allow the remote supervisor to determine and adapt dose, as well as terminate sessions as needed. After trial end, stimulation history analysis for each code provided can be performed by the supervisor at the clinic.
Dr. Abhishek Datta, CTO of Soterix Medical comments “The design and release of the mini-CT platform is significant for the entire field of neuromodulation by being the first device that allows transcranial Direct Current Stimulation (tDCS) to be applied outside of the academic center and clinic. The rational is clear: the effects of tDCS are believed to increase with repeated use but regular visits to the treatment center are a burden for patients and their care-givers, as well as demanding for the clinical trial site. For a decade, the potential for tDCS as a technology that could be used at home was discussed, but all clinical grade systems like the Soterix Medical 1x1-tDCS was not suitable for deployed use. The mini-CT is the first clinical grade tDCS device that can be used outside of the clinic while maintaining the tolerability and reproducibility.”
David Berger, Product Engineer who led the mini-CT design process adds: “First and foremost in the design of any SMI product is incorporation of the most advanced medical technology to ensure consistent performance. But built into all SMI devices is also a transparency of function with only the more salient information and controls provided to the operator- this is the SMI open panel principle. But the design of the mini-CT presented fundamentally new challenges because the supervisor would no longer be in the same room as the subject. The ability to achieve reproducible remote supervised tDCS is a first and should accelerate and transform the advancement of neuromodulation.”
CAUTION: Investigational device. Federal (or United States) law limits device to investigational use.
Media Contact Kamran Nazim
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