Soterix Medical devices provide unique performance as these products, the methods of manufacturing are the subject to one or more U.S. or foreign patients or pending applications including but not limited to US9956395B2, US8818515B2, US8718778B2.
Soterix Medical High-Definition transcranial Direct Current Stimulation (HD-tDCS) is a non-invasive technique where brain regions are targeted using arrays of electrodes on the scalp. In contrast to conventional tDCS, which uses large sponge electrodes, HD-tDCS uses our exclusive Soterix Medical “High-Definition” small gel based electrodes. This proprietary technology is the only hardware that allows safe and tolerated passage of current through small electrodes on the scalp, as validated in clinical trials. HD-tDCS provides users with tremendous flexibility in determining brain targets through the use of Soterix Medical Neurotargeting Software. Fully integrated with every HD-tDCS hardware system, Neurotargeting makes optimized and individualized therapy as easy as a push of a button.
Other technologies and devices marketed for “small electrode transcranial stimulation” are not endorsed by Soterix Medical and are counter-indicated for use with any Soterix Medical stimulator or software, including 4x1 HD-tDCS. Soterix Medical is committed to the advancement of rational non-invasive neuromodulation through application of the highest scientific and medical standards.
Given the flexibility of HD-tDCS, with independently controlled electrodes deployed anywhere on the head, software that allows simple and optimized set-up is critical. Soterix Medical developed Neurotargeting Software exactly for this purpose including a range of exclusive features all designed to make dose optimization for your clinical trial simple and convenient.
Soterix Medical developed HD-tDCS and clinicians trust our team of scientists and biomedical engineers to ensure every HD-tDCS devices is designed and manufactured based on the most state-of-the-art evidence and techniques. Soterix Medical is the industry standard for non-invasive brain stimulation and nowhere is this more important than in HD-tDCS.
Usability and simplicity underpin every Soterix Medical device and HD-tDCS is no exception. We recognize that state-of-the-art neuromodulation tools are only as effective as they can be understood and controlled by operators. Our human factors engineers review every aspect of HD-tDCS stimulator and accessories to ensure that advanced neuromodulation does not come at the cost of complexity in use. Our unparalleled customer support ensures you have all the guidance and support, when you need it.
Exclusively from Soterix Medical, HD-tDCS is the only clinically validated system for non-invasive and targeted neuromodulation.
Do not be compromised by un-tested copycat devices. Soterix Medical's unmatched team of biomedical engineers and scientists is ready to support you to deploy the right HD-tDCS system for your application.
There is only one electrode design that has been engineered for HD-tDCS, validated in extensive clinical testing, and used in clinical trials. The High Definition electrode was designed at The City University Of New York (Minhas 2010) and been proven safe and well tolerated in multi-center clinical trials (Borckardt 2012, Villamar 2013, Kuo 2013). It is critical investigators do not attempt multi-electrode stimulation with non-validated “off-brand” devices under the assumption these approaches have any relevance to Soterix Medical HD-tDCS technology or clinically validated approaches. Use of off-brand electrodes and devices compromise research integrity, patient safety, and interferes with the rational development of HD-tDCS by the research community.
In advanced neuromodulation design, software and hardware that allow arbitrary placement of HD electrodes on the head is required. Precision of montage matters critically, which is why stimulation software and supporting hardware must provide user with flexibility and precision in control. Don't be confused by copycat hardware and software that provides neither flexibility nor precision. State-of-the-art neurotargeting software and hardware, with flexibility and precision, exclusively from the industry leader in non-invasive electrical stimulation, brought to you by Soterix Medical.
Each Soterix Medical HD-tDCS 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 HD-tDCS. The Soterix Medical SmartScan feature is central in all HD-tDCS and tDCS devices to allow reliable set-up and monitoring.
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 HD-tDCS, SmartScan was developed by Soterix Medical engineers to provide clinical investigators with a simple to read indication of contact quality.
Clearly indicates the actual current supplied at the moment.
What other devices promise, the Soterix Medical HD-tDCS delivers. The back-lit display can be monitored during stimulation ramp up and to confirm target current intensity is achieved.
Simple and intelligent sham waveforms.
An automatic stimulation sham feature that is engaged with a simple switch. Auto-sham automatically calculates and produces a sham waveform based on the indicated “real” waveform. For example, for a corresponding real waveform of 1.5 mA and 10 minutes, auto-sham will provide a ramp up/down to 1.5 mA at the start of stimulation, and again after 10 minutes, with the timer automatically adjusted such that the total run time is exactly matched to the real case. Based on the Soterix Medical OpenPanel™ design principle: with no complicated programming or hidden drop-down menus required.
Provides continues monitoring of conditions during HD-tDCS
An exclusive technology from the trusted leader in neuromodulation, Soterix Medical HD-monitor is an intelligent oversight system that provides continuous monitoring of current flow conditions and can engage automatic ramp-down should unusual performance be detected. HD-tDCS is the most advanced non-invasive neuromodulation system, providing tremendous flexibility to operators. HD-monitor provides a further level of automatic over-sight before, during, and after stimulation.
The only platform designed to allow channel upgrades.
No other multi-channel stimulation systems is engineering to allow for scalability. The exclusive SCALABLE features integrated into every MxN device allows operators to feel comfortable knowing they can begin HD-tDCS with the most economical option without losing future scalability.
HD devices designed to integrate with Soterix Medical Neurotargeting Software.
Multichannel stimulation devices are only as customizable as the software used to design montages. With independent current control at each electrode with MxN devices, device power and flexibility requires intelligent montage design software. Neurotargeting software is the exclusive Soterix Medical solution to montage design and our HD-tDCS stimulator integrates seamlessly. Clinicians and scientists trust Soterix Medical engineers to provide the modeling and software sophistication to fully leverage HD-tDCS.
Optimized for the 4x1 HD-tDCS montage.
The 4x1 HD-tDCS montage remains the more popular and validated montage for unidirectional targeted brain neuromodulation. Devices optimized for 4x1 are designed to allow simple and consistent set-up including in high throughput clinical trials. Simple to use and designed by the inventors of 4x1 HD-tDCS, do not be confused by copycats and compromise the integrity of your trial and safety of your subjects. Soterix Medical Inc. (SMI) 4x1 certification is indicated on all validated 4x1 devices. *All MxN devices can provide 4x1 stimulation in addition to arbitrary configurations.
May be used to supply a very weak current prior to tDCS to help condition the skin.
Tickle may be used to both condition skin prior to tDCS or for naïve subject anxious about stimulation. A custom on-off waveform pattern generates mild and brief sensation under electrodes.
Allows the clinician to use a simple sliding bar to transiently decrease the current from the pre-set value, for example, based on subject feedback.
Based on feedback from leading clinical centers, Soterix Medical developed the exclusive feature Relax, which accommodates subjects who may be anxious when stimulation is initiated or during the course of stimulation. The Relax slider may be adjusted from full to reduced intensity based on subject perception without interrupting or aborting stimulation.