Soterix Medical Inc

Soterix Medical Inc

mini-CT

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The Soterix Medical mini-CT captures the features of the clinical trial standard 1x1-CT in a deployable platform. Supervised neuromodulation guarantees over 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 controlled and reliability in conducting tDCS or tES trials in deployed environments without compromising dose precision and safety.

mini-CT Device Features

Each Soterix Medical 1×1 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 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 Waveform
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
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
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.

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