1×1 tES Clinical Trials

The Soterix transcranial Direct Current Stimulator Clinical Trials (1×1-CT) system is the most advanced and customizable stimulation 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.

In addition, you can count on Soterix Medical biomedical engineers and scientists to provide continuous design and trial support.

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.