1×1 tDCS Clinical Trials

Transcranial Direct Current Stimulation (tDCS) for Clinical Trials

The only true double-blind, fully programmable, integrated system for transcranial electrical stimulation clinical trials.

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

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

Advanced technology supporting rigorous clinical trial design

  • Industry standard for multii-center clincial trials

  • Fully customized systems and protocols

  • Unmatched technical support and training

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-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.

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.

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 position. 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 operator 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 prevent 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 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.

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.

Clinical Trials

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.

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.

Neuromodulation of cognition in older adults

Study investigates whether transcranial direct current stimulation enhances the effects of cognitive training in healthy older adults.
Soterix Medical 1×1 tDCS device is being used in this study.

Treatment of chronic pelvic pain assosicated with Endometriosis.

The purpose of this study is to determine if transcranial direct current stimulation (tDCS) is effective in the treatment of chronic pelvic pain associated with endometriosis
Soterix Medical 1×1 tDCS device is being used in this study.

Open Label Treatment With tDCS for Parkinson's and Related Disorders.

The purpose of this study is to determine if treatment with tDCS for Parkinson's and Related Disorders has any improvement of Speech, Gait and Mood.
Soterix Medical 1×1 CT device is being used in this study.

Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment

The main idea of this study is that brain stimulation can enhance functioning in the specific brain regions/networks, thereby increasing the patients' ability to benefit from memory rehabilitation.
Soterix Medical 1×1 CT device is being used in this study.

Refractory Epilepsy Trial

High-Definition tDCS (HD-tDCS) clinical trial underway for Treatment of Refractory Partial Onset Epilepsy in adults and children at NYU School of Medicine.
Soterix Medical HD-tDCS device is being used in this study.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Fibromyalgia Clinical Trial

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

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.

tDCS Software

Optimization of electrode montage for brain targeting and individual subject customization has never been as easier 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.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.