One validated system, two device models
The Soterix Medical mini-CT captures the features of the clinical trial standard 1x1-CT in a deployable platform. Supervised neuromodulation guarantees over the site at the start and completion of every session, ensured by unique mini-CT features. Two models, the 1x1 tDCS mini-CT and the 1x1 tES mini-CT provide unmatched control and reliability in conducting tDCS or tES trials in deployed environments without compromising dose precision and safety.
1x1 tES mini-CT
- Remote supervised delivery of tDCS, tACS, tRNS, tPCS or tODCS
- tES-LTE enabled
- Simple interface
- Customized accessories
- Very compact design
- Secure administrator mode to program sessions
- Storage: 1800 Session
- Intelligent power management maximizes battery life
- Power: External AAA batteries
1x1 tDCS mini-CT
- Cost effective device for remote supervised tDCS
- tDCS-LTE enabled
- Simple interface
- Customized accessories
- Compact design
- Secure administrator mode to program sessions
- Storage: 250 Session
- Intelligent power management maximizes battery life
- Power: External AAA batteries
mini-CT Device Features
Each Soterix Medical 1×1 feature was developed by a 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 REMOTE Neuromodulation. The Soterix Medical SmartScan feature is central in all REMOTE Neuromodulation devices to allow reliable set-up and monitoring.
tES Waveform: Any tDCS, tACS, tRNS, toDCS Current intensities, durations and repetitions set in each discharge key. All output performance recorded. Dose can be adjusted based on patient response.
tDCS Wavform: tDCS Current intensities, durations and repetitions set in each discharge key. All output performance recorded. Dose can be adjusted based on patient response.
Limitation: Software (code) based dose limitation All Soterix Medical REMOTE Neuromodulation systems are equipped with strict dose control feature that provide reliable control over the intensity and timing of stimulation. The Dose Limitation feature extends well beyond simple timing control as Soterix Medical consider deploying a device without methods for ongoing monitoring by a professional and methodology to adjust and stop stimulation, not sufficient. Therefore, Dose Limitation technology is integrated with other clinical protocol features and steps unique to each REMOTE Neuromodulation device model. Dose Limitation can be achieved via hardware, software, or wireless supervision. Recognizing that “In Advanced Neuromodulation, One Size Does No Fit All”, Soterix devices are ready to customize dose control and compliance approaches to your needs.
LTE: For susceptible subjects, Limited Total Energy minimize power and energy delivery Limited Total Energy for tDCS (LTE-tDCS) was developed exclusively by Soterix engineers. LTE limits the voltage and power required for tDCS through the use of adaptive ramp-up stimulation and intelligent energy management for currents up to 1.5 mA.
Double Blind: Full integrated clinical trial support with subject codes and customized sham protocols Developed to support multi-center clinical trials in tDCS. Double Blind from Soterix optimizes well beyond traditional ramp up/down shams. 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. Since “one size does not fit all,” Soterix Medical scientists work with you to customize Double Blind to your active protocol and electrode montage.
Storage: Software (code) based usage storage Soterix Medical REMOTE Neuromodulation systems are all equipped with unique technology that allows monitoring of dose compliance. This data is collected in a way that is coded to the subject allowing the remote operator to quickly diagnose concerns. If stimulation is aborted or interrupted, impedance is abnormal, or other faults are detected by the device, the system will automatically abort or alter stimulation and the incident details stored. REMOTE Neuromodulation systems can also be configured to prompt users to survey data. Usage Storage can be achieved through varied combinations of hardware, software, or wireless supervision. Contact Soterix Medical to learn how REMOTE Neuromodulation systems can be programmed to your needs.
SMARTscan: 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.
PAUSE: A simple feature that minimizes dropout in double-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-blind trials.
Soterix Medical REMOTE Neuromodulation systems are governed by three design principles:
Supervised Care
REMOTE Neuromodulation starts and ends with a professional caregiver. Dose control, limits, and remote monitoring are ensured thought unique systems and controls.
Right Equipment
Accessories + intelligent hardware equipped with our proprietary LTE technology that are designed for safe and consistent application in deployed environment.
Trial Customization
Soterix Medical is the technology leader in noninvasive electrical stimulation and has developed advanced task-specific neuromodulation devices.
