The only true triple-blind, fully programmable, integrated system for transcranial electrical stimulation clinical trials. Unmatched reproducibility, unique sham control procedures, session by session dose control, compliance tracking, and intuitive accessories ensure unparalleled reliability and ease of use. The 1x1 CT system provides uncompromised safety and control.
Using basic systems, experienced operators can break blind, for example by observing impedance changes unique to the active arm. The CT interface panel is the only system for true double and triple blind clinical trials.
State-of-the-art tDCS trial design recognizes the limitations of basic sham protocols. CT systems use EASYpad electrodes to decrease sensation in the active arm and custom ramps to increase sensation in the sham.
When consistency across oppressors and centers cannot be compromised, each CT system comes with custom EASYstrap head-gear and accessories specific to the trial. Unique LTE technology and EASYpads provide for constant tolerability.
In extended trials, dropouts are costly and confound results. With features such as PAUSE integrated into customized devices, compliance is increased, saving time, cost, and reducing risk of failure due to lack of statistical power.
The Soterix transcranial Direct Current Stimulator Clinical Trials (1x1-CT) system is the most advanced and customizable stimulation for true double and triple 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.
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 and triple 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.
Full integrated clinical trial support with subject codes and customized sham protocols
Clinician and patient blinded study for unbiased results.
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 and triple 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 and triple blind trials.
Limited Total Energy for Clinical Trials
A Soterix Medical exclusive feature, LTE-CT adapts our proprietary LTE technology for higher stimulator outputs needed in the most advanced tDCS clinical trials. For current intensities of 2.0 mA and 2.5 mA, LTE-CT provides robustness and safety-factors essential for large scale tDCS clinical trial. For current intensities > 2.5 mA, please contact Soterix Medical.
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.
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.
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.
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.
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
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.
Because non-invasive brain stimulation, such as tDCS, requires delivery of energy through the scalp to the brain, the design of appropriate sham controls is pivotal for reliable clinical trial results. Two complimentary approaches can be taken. In the sham study, skin sensation should be maximized while minimizing current delivery to the brain. In the real study arm, sensation should be reduced using optimized ramp waveform and electrodes, while maintaining brain stimulation dose. If the active arm can be reduced to levels where stimulation is imperceptible to a majority of subjects, the sham arm becomes trivial to design. Conversely, electrode waveforms can be designed to enhance sensation during the sham arm, without significant brain current flow. Indeed, many of the processes used to reduce sensation during the active arm during full intensity stimulation, can be “reversed” to increase sensation in the sham arm even during weak stimulation. The most straightforward tDCS sham includes a transient ramp on and off. However even here there are several permutations including the rate of ramp increase, rate of ramp decrease, maximum intensity of ramp (which may or may not match real stimulation intensity), and the timing and number of ramps. A transient ramp may be applied only at the start of stimulation, only at the start or end, or at intermittent (even randomized) points during the session. Soterix Medical biomedical engineers and scientists are ready to work with you to design the right sham protocol for your trial.
Soterix Medical EASYpads™ are designed to minimize sensation consistently across subjects while allowing reproducible and controlled set-up. Soterix Medical EASYpads™ are the standard choice for single and multi-center tDCS clinical trials. Soterix Medical SHAMpads™ are the first tDCS electrodes to include built in scalp shunting paths, that are controlled by the CT stimulator and are operator blind. During the active arm, SHAMpads™ deliver current through HD-electrode functional sets, which mimic the current delivery of pad stimulation but are imperceptible for a majority of conventional tDCS protocols. During the sham arm, SHAMpads™ shunt current under the electrodes allowing the reproduction of any sensation level with no brain current flow. SHAMpads™ are compatible only with the Soterix Medical 1x1-CT unit and Soterix Medical HD-tDCS neuromodulation systems.
Optimization of electrode montage for brain targeting and individual subject customization has never been as easy as with Soterix Medical's Neurotargeting software. With recognition that placing an electrode "over" a target does not support rational tDCS does design, the Soterix Medical Suite of software tools allow simple and automatic optimization. Soterix Neurotargeting software also provides high-resolution current flow visualization that can be used to support publications, presentation and proposals.