The Soterix Medical 1×1 CT system is unique in providing four features for double and triple blind clinical trials

• True Operator Blinding: The CT interface panel is the only system for true double and triple blind clinical trials.
• True Subject Blinding: CT systems use EASYpad electrodes to decrease sensation in the active arm and custom ramps to increase sensation in the sham.
• Reliability: When consistency across oppressors and centers cannot be compromised, each CT system comes with custom EASYstrap head-gear and accessories specific to the trial.
• Avoid Dropout: 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 1×1 CT is customizable for True Double and Triple 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.

A Complete System and Process Controls
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

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.

Reproducible and Consistent Stimulation Set-up

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.

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.

Avoid Subject Drop-Out With PAUSE and LTE

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.

Subject Blinding For True Sham

Soterix Medical EASYpads™ are designed to minimize sensation consistently across subjects while allowing reproducible and controlled set-up.

Triple Blind: Full integrated clinical trial support with subject codes and customized sham protocols

SMARTscan Plus: Provides a continuous visual indication of electrode quality before and during stimulation.

Pause: A simple feature that minimizes dropout in double and triple blind clinical trials

LTE-CT: Limited Total Energy for Clinical Trials