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1×1 Clinical Trials
Reference : 150x
Soterix transcranial Direct Current Stimulator Clinical Trials (1x1-CT) system is the most advanced & customizable stimulation for true double-blind control trials. Each 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 & safety, all without breaking subject’s or operator’s blind.
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|LTE||Limited total energy provides adaptive ramp-up stimulation technology to limit the required voltage|
|Double Blind||Clinician and patient blinded study for unbiased results|
|SMARTscan Plus||Provides a continuous visual indication of electrode quality before and during stimulation without compromising blind|
|Pause||Stop stimulation during a session and resume later to complete the session|
The Soterix Medical 1x1 CT is complete with 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.
Clinician and patient blinded study for unbiased results.
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.
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.
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.
Feel free to contact our engineers at Caputron to assist you with your endeavors, we would love to help!