The only true double-blind, fully programmable, integrated system for transcranial electrical stimulation clinical trials.
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 (1×1-CT) system is the most advanced and customizable stimulation for true double-blind control trials. Each 1×1-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.
Each 1×1 CT unit is shipped with accessories and relevant features to ensure the highest standards of reproducibility and safety.
In addition, you can count on Soterix Medical biomedical engineers and scientists to provide continuous design and trial support.
A Complete System and Process Controls
The Soterix Medical 1×1 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 1×1-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.
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.
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 1×1-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.
Clinical trial design begins with dose selection and optimization, the Soterix Medical 1×1- CT design process begins by leveraging Soterix Medical Neurotargeting™ and in-house expertise on dose design.
Soterix Medical custom solution reports, figures, and images can also be used to enhance rigor in presentations and publications.
Reproducible and Consistent Stimulation Set-up
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.
Each Soterix Medical 1×1 CT system is optimized for the specific trial montage and may be programmed to prevent stimulation initiation below a quality threshold.
Soterix Medical developed the SMARTscan™ for its 1×1 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 1×1-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 1×1-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 1×1-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 1×1-CT monitors, records, and provides a coded summary for study coordinators for post-session analysis. The 1×1-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 1×1-CT unit.
Subject Blinding For True Sham
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 1×1-CT unit and Soterix Medical HD-tDCS neuromodulation systems.
Learn more about Soterix Medical 1×1 tES Clinical Trials device, please click https://soterixmedical.com/research/1×1/ct or reach us at contact@amperemedical.com.hk.