Soterix 1×1 CT is The Most Advanced And Customizable System For True Double-Blind Control Trials

The Soterix transcranial Direct Current Stimulator Clinical Trials (1x1-CT) system is the most advanced and customizable stimulation for true double-blind control trials. Each 1x1-CT unit is shipped configured to a specific trial or set of trials, including custom accessories, and relevant features to ensure the highest standards of reproducibility and safety, all without breaking subject’s or operator’s blind.

In addition, you can count on Soterix Medical biomedical engineers and scientists to provide continuous design and trial support.

“Each 1x1 CT unit is shipped with accessories and relevant features to ensure the highest standards of reproducibility and safety.”

A Complete System and Process Controls

“Each CT device is programmed for stimulation, quality monitoring and real time alerts, and data storage on a trial specific basis. Each clinical trial is supported by Soterix Medical Neurotargeting™ and custom head-gear design.”

The Soterix Medical 1x1 CT is a complete tDCS clinical trial hardware, software, and data management platform designed to the highest standard in pivotal single and multi-center clinical trials. Each CT device is programmed for stimulation, quality monitoring and real time alerts, and data storage on a trial specific basis*. Each clinical trial is supported by Soterix Medical Neurotargeting™ and custom head-gear design. With SMARTscan-PLUS™ and an on-board controller automatically managing real and sham sessions, the Soterix Medical 1x1-CT is the only tDCS stimulator allowing for both true double blind of experienced investigators and for simple operation by new users. Because “one size does not fit all” in rational tDCS therapy and trial design, Soterix Medical biomedical engineers work with clinical investigators to address all tDCS technical aspects.

Dose Optimization

Though tDCS is a simple technique, it offers tremendous dose flexibility through selection of electrode positions, current intensity, and current duration. Clinical trial design begins with dose selection and optimization. Whether it is optimizing electrode montage to target cortical or deep brain regions, optimizing dose for anatomical variations, or even individualizing therapy, the Soterix Medical 1x1-CT design process begins by leveraging Soterix Medical Neurotargeting™ and in-house expertise on dose design. The heuristic concept of placing the “active” electrode “over” the target and the “return” electrode over an “indifferent” region no longer applies for rational tDCS design. Use Soterix Medical Neurotargeting™ and dose design to ensure that you don’t miss your target or affect undecided collateral reasons.

Soterix Medical custom solution reports, figures, and images can also be used to enhance rigor in presentations and publications.

“Clinical trial design begins with dose selection and optimization, the Soterix Medical 1x1- CT design process begins by leveraging Soterix Medical Neurotargeting™ and in-house expertise on dose design.”

Reproducible and Consistent Stimulation Set-up

“Each Soterix Medical 1x1 CT system is optimized for the specific trial montage and may be programmed to prevent stimulation initiation below a quality threshold.”

Protocol design and dose optimization is ineffective if electrodes are not positioned and prepared properly in the field. Using either standard or customized EASYstraps™, each clinical site is provided with a simple to use fixed electrode-positioning system. Consistent and reproducible electrode position is as simple as snapping in the EASYpads™ and sliding over the EASYstraps™ via corner rivets to pre-determined set electrode position. The EasyPads™ are designed for reliable current delivery with uniform current density at the skin using the patented corner-rivet dispersion and pad material optimized for consistent saturation and fluid retention. The use of EASYkits™ further simplifies and homogenizes electrode preparation across operators and sites and eliminates the potential for process substitution.

Soterix Medical developed the SMARTscan™ for its 1x1 systems to facilitate electrode set-up and preparation. A simple read-out provides an indication of electrode contact quality (Note: device read-out should never replace operator judgment and protocol). For the 1x1-CT system, Soterix Medical developed the SMARTscan-PLUS™ to monitor stimulation electrode contact quality specifically. This new feature is optimized for the specific trial montage and may be programmed to prevent stimulation initiation below a quality threshold. Experienced users benefit from rapid and consistent set-up facilitated by the easy read-out display. New users benefit from intuitive guidance in set-up.

Operator Blinding for True Sham

Each Soterix Medical CT unit is programmed, validated, and shipped direct from the factory with study and site-specific Stimulation Codes. These stimulation codes are developed based on the lead investigators clinical study plan and can be disclosed, encoded or un-encoded to the study coordinator or the statistician. However, for true operator blinding, stimulation codes are just the beginning. 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. For example, experienced operators will understand what change in electrode impedance is expected during an active tDCS session since current passage itself generates characteristic impedance decreases – thus breaking blind on conventional stimulators. Similarly, in real but not sham conditions when a faulty condition is detected, such as high voltage, requiring corrective action, blind on conventional stimulator is broken. The 1x1-CT stimulator provides continuous indication of electrode quality through the exclusive SMARTscan-PLUS™. Once the real and sham study protocols are set, Soterix Medical biomedical engineers tune the SMARTscan-PLUS™ algorithms to provide a simple indication of stimulation conditions that is consistent across real and sham conditions. New operators can rely on the SmartSCAN-PLUS™ indicators: “Green” Optimum: Within defined range; “Yellow” Moderate: Caution or attention warranted; “Red” Critical (LTE): Outside of defined range. For each trial, the operating manual will indicate requisite corrective steps. Experienced operator will not be able to distinguish real from sham sessions. True operator blind is thus achieved without compromising subject monitoring.

Soterix Medical custom solution reports, figures, and images can also be used to enhance rigor in presentations and publications.

Avoid Subject Drop-Out With PAUSE and LTE

Especially for trials where recruitment is challenging or where multi-sessions with each subjects make drop-out costly, Soterix Medical PAUSE™ and LTE™ features are enabled on the 1x1-CT. For example, pivotal trials often use multi-session stimulation over multiple days to enhance effects and may further employ a cross-over design – in such situations, the need to stop or interrupt stimulation on a single session can result in costly subject drop-out or confounding of results across the entire analysis. Furthermore, especially in large trials, interruptions in stimulation due to electrode-quality or subject concerns may occur. Soterix Medical biomedical engineers will work with study’s lead investigators to design hardware and software that

• minimizes the occurrences of interruptions
• allows for controlled, managed, and documented interruptions.

“The Soterix Medical PAUSE™ feature was developed to allow for controlled interruptions without the need to re-start stimulation or remove the subject from trial analysis.”

Minimize the occurrence of interruptions: Though designed for stimulation in susceptible populations, Soterix Medical LTE™ can be adapted for all clinical trials to minimize interruptions – under high resistance conditions stimulation intensity is automatically reduced while the operator is alerted to take corrective actions.   The 1x1-CT monitors, records, and provides a coded summary for study coordinators for post-session analysis.  The 1x1-CT intelligent sham feature ensures that alerts are provided at an equal rate under Real and Sham conditions. Allow for controlled interruptions:  The Soterix Medical PAUSE™ feature was developed to allow for controlled interruptions without the need to re-start stimulation or remove the subject from trial analysis. Activation of PAUSE™, ramps down stimulation in a prescribed manner (or simulates ramp-down settings for the sham case), thus allowing the operator to address electrode or subject controls.  Re-pressing PAUSE™, allows the operator to resume the session. If stimulation electrode quality condition goes out of range “Red” (LTE-critical event) and stays out of range for an extended period of time, PAUSE™ is automatically activated and current ramps down. This feature ensures subject safety/comfort by making sure that “out-of-range” stimulation does not continue for prolonged periods. The number of critical events per session and the time spent in the critical event mode are recorded by the CT unit and encoded.  Like with the LTE™ feature, the clinical trial is not designed with the expectation PAUSE™ will be required but, none-the-less, the PAUSE™ feature prevent either unnecessary subject drop-out or operators improvising steps in a manner that may compromise trial integrity. Soterix Medical features LTE and PAUSE can be enabled on any 1x1-CT unit.