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1×1 tES Clinical Trials

Transcranial Electrical Stimulation (tES) for Clinical Trials

The only true triple-blind, fully programmable, integrated system for transcranial electrical stimulation clinical trials. Unmatched reproducibility, unique sham control procedures, session by session dose control, compliance tracking, and intuitive accessories ensure unparalleled reliability and ease-of-use. The 1x1 CT system provides uncompromised safety and control.

Soterix Medical tES CT Device

The Soterix Medical 1x1 CT system is unique in providing four features for double and triple blind clinical trials

True Operator Blinding

Using basic systems, experienced operators can break blind, for example, by observing impedance changes unique to the active arm. The CT interface panel is the only system for true double and triple blind clinical trials.

True Subject Blinding

State of the art tDCS trial design recognizes the limitations of basic sham protocols. 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. Unique LTE technology and EASYpads provide for constant tolerability.

Avoid Dropout

In extended trials, dropouts are costly and confound results. 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.

Soterix 1×1 CT is The Most Advanced And Customizable System For True Double and Triple Blind Control Trials

The Soterix transcranial Direct Current Stimulator Clinical Trials (1x1-CT) system is the most advanced and customizable stimulation for true double and triple blind control trials. Each 1x1-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.

“Each 1x1 CT unit is shipped with accessories and relevant features to ensure the highest standards of reproducibility and safety.”

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.”

The Soterix Medical 1x1 CT is a complete 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 and triple 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.

Device Features

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

Clinician and patient blinded study for unbiased results.

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.

A simple feature that minimizes dropout in double and triple 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 and triple blind trials.

Limited Total Energy for Clinical 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. For current intensities > 2.5 mA, please contact Soterix Medical.
Request Product Information1×1 CT Manual & Specifications

Dose Optimization

Though tDCS is a simple technique, it offers tremendous dose flexibility through selection of electrode positions, current intensity, and current duration. Clinical trial design begins with dose selection and optimization. Whether it is optimizing electrode montage to target cortical or deep brain regions, optimizing dose for anatomical variations, or even individualizing therapy, the Soterix Medical 1x1-CT design process begins by leveraging Soterix Medical Neurotargeting™ and in-house expertise on dose design. The heuristic concept of placing the “active” electrode “over” the target and the “return” electrode over an “indifferent” region no longer applies for rational tDCS design. Use Soterix Medical Neurotargeting™ and dose design to ensure that you don’t miss your target or affect undecided collateral reasons.

Soterix Medical custom solution reports, figures, and images can also be used to enhance rigor in presentations and publications.

“Clinical trial design begins with dose selection and optimization. The Soterix Medical 1x1-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 1x1 CT system is optimized for the specific trial montage and may be programmed to prevent stimulation initiation below a quality threshold.”

Protocol design and dose optimization is ineffective if electrodes are not positioned and prepared properly in the field. Using either standard or customized EASYstraps™, each clinical site is provided with a simple-to-use, fixed electrode-positioning system. Consistent and reproducible electrode position is as simple as snapping in the EASYpads™ and sliding over the EASYstraps™ via corner rivets to pre-determined set electrode positions. The EASYpads™ are designed for reliable current delivery with uniform current density at the skin using the patented corner-rivet dispersion and pad material optimized for consistent saturation and fluid retention. The use of EASYkits™ further simplifies and homogenizes electrode preparation across operators and sites and eliminates the potential for process substitution.

Soterix Medical developed the SMARTscan™ for its 1x1 systems to facilitate electrode set-up and preparation. A simple read-out provides an indication of electrode contact quality (Note: device read-out should never replace operator judgment and protocol). For the 1x1-CT system, Soterix Medical developed the SMARTscan-PLUS™ to monitor stimulation electrode contact quality specifically. This new feature is optimized for the specific trial montage and may be programmed to prevent stimulation initiation below a quality threshold. Experienced users benefit from rapid and consistent set-up facilitated by the easy read-out display. New users benefit from intuitive guidance in set-up.

Stimulation codes are just the beginning

For true operator blinding

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. However, for true operator blinding, stimulation codes are just the beginning. 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.

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. However, for true operator blinding, stimulation codes are just the beginning. 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. For example, experienced operators will understand what change in electrode impedance is expected during an active tDCS session since current passage itself generates characteristic impedance decreases – thus breaking blind on conventional stimulators. Similarly, in real but not sham conditions when a faulty condition is detected, such as high voltage, requiring corrective action, blind on conventional stimulator is broken. The 1x1-CT stimulator provides continuous indication of electrode quality through the exclusive SMARTscan-PLUS™. Once the real and sham study protocols are set, Soterix Medical biomedical engineers tune the SMARTscan-PLUS™ algorithms to provide a simple indication of stimulation conditions that is consistent across real and sham conditions. New operators can rely on the SmartSCAN-PLUS™ indicators: “Green” Optimum: Within defined range; “Yellow” Moderate: Caution or attention warranted; “Red” Critical (LTE): Outside of defined range. For each trial, the operating manual will indicate requisite corrective steps. Experienced operators will not be able to distinguish real from sham sessions. True operator blind is thus achieved without compromising subject monitoring.

Soterix Medical custom solution reports, figures, and images can also be used to enhance rigor in presentations and publications.

Avoid Subject Drop-Out With PAUSE and LTE

Especially for trials where recruitment is challenging or where multi-sessions with each subjects make drop-out costly, Soterix Medical PAUSE™ and LTE™ features are enabled on the 1x1-CT. For example, pivotal trials often use multi-session stimulation over multiple days to enhance effects and may further employ a cross-over design – in such situations, the need to stop or interrupt stimulation on a single session can result in costly subject drop-out or confounding of results across the entire analysis. Furthermore, especially in large trials, interruptions in stimulation due to electrode-quality or subject concerns may occur. Soterix Medical biomedical engineers will work with study’s lead investigators to design hardware and software that:

  • minimizes the occurrences of interruptions
  • allows for controlled, managed, and documented interruptions.

“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.”

Minimize the occurrence of interruptions: Though designed for stimulation in susceptible populations, Soterix Medical LTE™ can be adapted for all clinical trials to minimize interruptions – under high resistance conditions, stimulation intensity is automatically reduced while the operator is alerted to take corrective actions. The 1x1-CT monitors, records, and provides a coded summary for study coordinators for post-session analysis. The 1x1-CT intelligent sham feature ensures that alerts are provided at an equal rate under Real and Sham conditions. Allow for controlled interruptions: 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. Activation of PAUSE™, ramps down stimulation in a prescribed manner (or simulates ramp-down settings for the sham case), thus allowing the operator to address electrode or subject controls.  Re-pressing PAUSE™, allows the operator to resume the session. If stimulation electrode quality condition goes out of range “Red” (LTE-critical event) and stays out of range for an extended period of time, PAUSE™ is automatically activated and current ramps down. This feature ensures subject safety/comfort by making sure that “out-of-range” stimulation does not continue for prolonged periods. The number of critical events per session and the time spent in the critical event mode are recorded by the CT unit and encoded.  Like with the LTE™ feature, the clinical trial is not designed with the expectation PAUSE™ will be required but, none-the-less, the PAUSE™ feature prevents either unnecessary subject drop-out or operators improvising steps in a manner that may compromise trial integrity. Soterix Medical features LTE and PAUSE can be enabled on any 1x1-CT unit.

Subject Blinding For True Sham

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

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 or end of stimulation, 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.

Soterix Medical EASYpads™ are designed to minimize sensation consistently across subjects while allowing reproducible and controlled set-up. Soterix Medical EASYpads™ are the standard choice for single and multi-center tDCS clinical trials. Soterix Medical SHAMpads™ are the first tDCS electrodes to include built-in scalp shunting paths that are controlled by the CT stimulator and are operator blind. During the active arm, SHAMpads™ deliver current through HD-electrode functional sets, which mimic the current delivery of pad stimulation but are imperceptible for a majority of conventional tDCS protocols. During the sham arm, SHAMpads™ shunt current under the electrodes allowing the reproduction of any sensation level with no brain current flow. SHAMpads™ are compatible only with the Soterix Medical 1x1-CT unit and Soterix Medical HD-tDCS neuromodulation systems.

Featured Clinical Trials

Completed

NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis

The study team is investigating whether or not transcutaneous auricular vagus nerve stimulation (taVNS) can treat neurologic symptoms of COVID-19 which are termed NEUROCOVID.

Access complete clinical trial information here

More on Soterix Medical taVNS platforms

Completed

Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis: A Phase II Randomized Sham-Controlled Trial

The purpose of this study is to assess the feasibility, acceptability, and efficacy of self-administered transcranial direct current stimulation (tDCS) in older adults with knee osteoarthritis (OA)

Access complete clinical trial information here

More on Soterix Medical Remote tDCS Platforms

Completed

Home-Administered Trial of Direct Current Stimulation (HAT-DCS)

This study will evaluate the feasibility and efficacy of home-administered transcranial Direct Current Stimulation (tDCS) treatment for depression.

Access complete clinical trial information here

More on Soterix Medical Remote tDCS Platforms

Completed

tDCS-LTE Major Depression Disorder Trial

FDA IDE trial of transcranial Direct Current Stimulation-Limited Total Energy (tDCS-LTE) neuromodulation at-home for patients with Major Depressive Disorder (MDD).

More on Soterix Medical Remote tDCS Platforms

tSDCS to Enhance Locomotion After Spinal Cord Injury

This study will investigate the effects of transcutaneous direct current stimulation (tsDCS) on walking function in individuals with incomplete spinal cord injury.

Access complete clinical trial information here

More on Soterix Medical tSDCS System

Completed

tDCS for the Management of Multiple Sclerosis Related Fatigue

Pragmatic clinical trial that aims to determine the effect of tDCS on symptomatic fatigue in Multiple Sclerosis (MS) patients. This is a randomized, blinded, sham-controlled study design to determine the effect of Transcranial Direct Current Stimulation (tDCS) on MS participants to reduce feelings of fatigue.

Access complete clinical trial information here

More on Soterix Medical 1x1 mini-CT

Completed

Impact of Neuromodulation on Language Impairments in Stroke Patients: a Multimodal Double-blind Randomized Controlled Study

Due to the limited effectiveness of conventional speech therapy strategies in post-stroke aphasia an effective novel treatment is therefore needed to improve recovery in these patients. A double-blind randomized controlled design will be conducted. Participants will randomly be assigned either to the tDCS group or to the sham (placebo) group.

Access complete clinical trial information here

More on Soterix Medical transcranial Direct Current Stimulator Clinical Trials (1x1-CT) system

Completed

Transcranial Direct Current Stimulation in Major Depression

Study aims to understand and determine how tDCS works, how it can be optimized, and if it can be used as an effective intervention for reducing depressive symptoms in people suffering from Major Depression

Access complete clinical trial information here

More on Soterix Medical MxN line of stimulators

Completed

Augmenting Cognitive Training in Older Adults (ACT)

Trial will assess the individual and combined impact of pairing cognitive training with tDCS in adults (65-89 years).

Soterix Medical 1x1 Clinical Trials (CT) device using Limited Total Energy (LTE™) technology is being used in the study.

Access complete clinical trial information here

More on Soterix Medical More on Soterix Medical 1x1 CT stimulator

Completed

Cathodal tDCS in MCI: A Randomized, Double-Blind, Sham-Controlled Pilot Study

This study evaluates the application of non-invasive brain stimulation in the treatment of Mild Cognitive Impairment (MCI) in adults aged 55-85.

Soterix Medical 1x1 tES device is being used in the study.

Access complete clinical trial information here

More on Soterix Medical More on Soterix Medical 1x1 tES stimulator

Completed

Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees

This study explores the effects transcranial Direct Current Stimulation on Phantom Limb Pain for patients experiencing chronic phantom limb pain in open-label study design.

Soterix Medical 1x1 tDCS device is being used in the study.

Access complete clinical trial information here

More on Soterix Medical 1x1 tDCS stimulator

Completed

MARt-Depression Trial

The purpose of the pilot study will be to evaluate the feasibility of open label Transcranial direct current stimulation (tDCS) in combination with computerized cognitive behavior therapy (cCBT) to maintain wellness following an acute course of Electroconvulsive therapy (ECT) for up to 6 months.

Soterix Medical 1x1 tDCS mini-CT device is being used in the study

Access complete clinical trial information here

More on Soterix Medical 1x1 CT stimulator

Completed

tDCS for the Treatment of Bipolar Depression

Soterix Medical 1x1 Clinical Trials device with Limited Total Energy (LTE) to be used in a trial to study the antidepressant effects of tDCS in bipolar disorder.

Enrollment information at NIH ClinicalTrials.Gov

More on Soterix Medical LTE™ and CT

Completed

tDCS and Talking Therapy for Aphasia

Hunter College of The City University of New York will investigate the use of Soterix Medical 1x1 tDCS (transcranial direct current stimulation) in conjunction with speech-language therapy, for the improvement of language production in stroke survivors with aphasia.

Enrollment information at NIH ClinicalTrials.Gov

More on Hunter College.

Completed

Phase III Clinical Trial for major depressive disorder

Trial will compare Soterix Medical tDCS-LTE™ technology against a fully dosed, effective antidepressant Escitalopram oxalate (Lexapro). Recruitment ongoing.
Soterix Medical 1×1 Clinical Trials (CT) device using Limited Total Energy (LTE™) technology is being used in the study.

Access complete clinical trial information here

More on Soterix Medical LTE™ and CT

Completed

Effects of tDCS on Motor Learning in Children With Cerebral Palsy (CP)

Trial will assess the clinical and neurophysiological effects of a non-invasive brain stimulation technique - transcranial direct current stimulation (tDCS)- on cortical plasticity and motor learning in children with cerebral palsy.

Access complete clinical trial information here

More on Soterix Medical 1×1 stimulator

Completed

Cognitive Stimulation Study (CogStim)

This study will evaluate the influence of non-invasive brain stimulation on different elements of cognitive function in healthy persons between the ages of 18-90 years. Soterix Medical 1×1 tDCS device is being used in this study.

Access complete clinical trial information here

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Completed

Neuropathic Symptoms Following Burn Injury Trial

Spaulding Rehabilitation Hospital and the US Department of Education will investigate the effects of Soterix Medical 1x1 transcranial direct current stimulation (tDCS) on the pain and itching associated with burn injury. This study is part of the Boston-Harvard Burn Model System.

Enrollment information at NIH ClinicalTrials.Gov

More on the Boston-Harvard Burn Injury Model System

Completed

Phase II Fibromyalgia Trial

Follow up Phase II, HD-tDCS clinical trial underway for fibromyalgia at Harvard Medical School and Spaulding Rehabilitation Hospital, and in conjunction with Elminda Corporation. Exclusive Soterix 4x1 HD-tDCS being used.

Enrollment information at NIH ClinicalTrials.Gov

More information on the Spaulding Neuromodulation Lab

Completed

Abdominal pain in patients with chronic pancreatitis Clinical Trial

This study is testing whether the addition Soterix Medical 1x1 transcranial direct current stimulation (tDCS) when combined with meditation helps decrease the abdominal pain in patients with chronic pancreatitis.

Enrollment information at NIH ClinicalTrials.Gov

More on Soterix Medical 1×1 Devices.

Completed

Corneal Pain Clinical Trial

Study focused on investigating effect of tDCS on chronic corneal pain as well as changes in thought processing as compared to healthy controls. Soterix 1×1 Device is being used.

Access complete clinical trial information here

Boston Foundation of Sight

Completed

Stroke Recovery Clinical Trial

Study focused on evaluating the effect of a combination of robotic arm therapy and transcranial Direct Current Stimulation for greater functional recovery after stroke.

Access complete clinical trial information here

North Shore Long Island Jewish Health System

Completed

Depression Clinical Trial

For the most comprehensive tDCS trial to-date, researchers selected the most advanced tDCS device and the only system optimized for clinical trials – The Soterix Medical 1x1-CT.

Enrollment information at NIH ClinicalTrials.Gov

Clinical Trials tDCS Devices by Soterix

Completed

Pediatric Epilepsy Trial

Epilepsy Foundation awards a New Therapy Grant for a clinical trial of High-Definition tDCS in pediatric epilepsy. Dr. Alexander Rotenberg will lead a team of clinical investigators including at BCH and Harvard Medical School.

Custom Solutions

Epilepsy Foundation

Completed

Stroke Rehabilitation Trial

NIH grants Burke Medical Research Institute $3m to conduct the most controlled trial of tDCS for stroke rehabilitation to date. The Soterix Medical 1x1 platform is the most advanced and the industry standard for tDCS clinical trials for rehabilitation.

More Details at NIH

tDCS lab at Burke Rehab.

Completed

Down Syndrome Trial

Soterix Medical Inc. receives FDA Clinical Trial IDE for High-Definition tDCS (HD-tDCS) to improve IQ in pediatric Down syndrome. HD-tDCS is the only non-invasive, brain targeted, and low-intensity technology designed to promote neuroplasticity.

Soterix Medical INC. HD-tDCS

Soterix Medical INC. Limited Total Energy (LTE™) for Susceptible Populations

More Info. at NIH

Completed

Pediatric Hemiparesis Trial

Dr. Bernadette Gillick's Pediatric Rehabilitation Laboratory is supported by the NIH and University of Minnesota Clinical and Translational Science Institute to investigate the use of a form of tDCS for interventions in rehabilitation for children. Subject specific analysis with Soterix Medical Neurotargeting™ will guide current to brain cells in the injured part of the brain.

More info at Uni. of Minnesota.

More Information of Clinical trials

Completed

Fibromyalgia Clinical Trial

HD-tDCS clinical trial underway for fibromyalgia at Harvard Medical School and Spaulding Rehabilitation Hospital, Boston.

Enrollment information at NIH ClinicalTrials.Gov

More info at Massachusetts CFIDS/ME & FM Association

Completed

Stroke Rehabilitation Clinical Trial

NIH grants Soterix a Phase-1 STTR grant to develop HD-tDCS for stroke rehabilitation. The first technology capable of delivering therapeutic direct current to target brain regions involved in functional recovery.

Clinical trials at The Aphasia Lab at The University of South Carolina

tDCS Software

Optimization of electrode montage for brain targeting and individual subject customization has never been as easy as with Soterix Medical's Neurotargeting software. With recognition that placing an electrode "over" a target does not support rational tDCS does design, the Soterix Medical Suite of software tools allow simple and automatic optimization. Soterix Neurotargeting software also provides high-resolution current flow visualization that can be used to support publications, presentation and proposals.

HD-Explore

Current flow simulation

Rationally plan HD-tDCS trial using state of the art modeling. Emulate any tDCS or tACS montage.

HD-Targets

Automatic optimization

Revolutionary non-invasive targeting software for optimal brain stimulation therapy.

1×1 CT + MRI

Soterix Medical 1×1 CT systems can be used in the fMRI/MRI using a unique 1×1 CT-MRI kit. These complete kits provide an easy solution for full integration of our 1×1 CT stimulator with MRI/fMRI. The setup is rated to be compatible with any sequence in a 7T machine in Normal and First Level modes.

Soterix Medical Engineers have designed the MRI/fMRI accessories while keeping in mind the subject’s safety, stimulation tolerability, and the operator's ease-of-use. The unique setup uses filters through the patch panel for exceptional RF noise control, providing unmatched reliability. Learn more...

Unique Soterix Medical IFS-MRI kit
Caution! Investigational Device. Federal (or United States) law limits device to investigational use.