Sooma tDCS Device

Sooma tDCS is an effective and easy-to-use solution for professionals, optimised for use in clinical routine. Sooma is the optimal tool for outcome studies. It supports double-blind conditions and can be configured for multiple study protocols. When combined with the included remote patient management software, Sooma tDCS provides state-of-the-art home-based neuromodulation. Log in with your web browser and in 2 minutes, you know how all your home-based patients are doing.

Investigational Device. This product is currently limited to researchers or medical doctors. Please fill out the form below for additional information and pricing.

In the USA, Sooma tDCS is labeled as an investigational device. Its use is limited to researchers or medical doctors. In the EU, Sooma tDCS adds a new dimension to the clinical routine for treating patients with major depression or chronic pain. Sooma tDCS delivery kit includes all you need to get started with your tDCS trials.

  • Safe and well tolerated
  • Effective
  • Easy to use, designed for clinical routine or research studies
  • Affordable and cost-effective
  • Can be used as monotherapy or as adjunct to other treatments
Sooma tDCS Device Starter Kit

Features

  • Intuitive workflow-based operation
  • Single button, no possibility for accidental modification of treatment protocol
  • Continuous contact monitoring for dose control
  • Current ramp-up and ramp-down for patient comfort
  • Treatment counter for use supervision
  • Sham-mode for double-blind operation

In the USA, this device is available for investigational use. Sooma tDCS is a class IIa medical device CE approved in the EU for treatment of Major Depressive Disorder, Fibromyalgia, and Neuropathic pain. It is an effective and easy-to-use solution for professionals, designed for routine clinical use in co-operation with leading psychiatrists and neurophysiologists.

The stimulation is gentle and very well tolerated. It can be used as an alternative to or in combination with psychotherapy, pharmaceuticals, and other neuromodulation treatments.

Sooma tDCS is an optimal tool for outcome studies. It supports double-blind condition and can be configured for multiple study protocols. Further, it ensures that every member of the study team perform stimulation in the same way.

Device specifications

  • Adjustable current up to 3 mA in increments of 0.1 mA
  • Adjustable application time up to 30 min in increments of 30 sec
  • Current ramp up / ramp down: 0.1 mA/s
  • Maximum output voltage: 18 V
  • Battery life: 100 hours. User replaceable.
  • Single-button session control
  • Compact size: 12 cm x 7.3 cm x 2.2 cm
  • Weight (incl. batteries): 0.2 kg
  • Touch-proof electrode connection in accordance with DIN 42802
  • Ingress protection: IP21

How to Use Sooma tDCS

When starting a session, two electrodes are positioned over the stimulation area using a head cap that offers the intuitive usability required in clinical routine. The device ensures that the contact between scalp and electrodes is acceptable. When acceptable contact is achieved, the device allows the user to start the stimulation. Sooma offers several sizes of head caps to accommodate to different head sizes. The whole treatment preparation usually takes less than 5 minutes.

During a stimulation session, direct current is applied directly to the scalp at the stimulation area. The current intensity is 2 mA, which is 400 to 500 times less than in traditional electroconvulsive therapy (ECT).

Sooma remote supervision for home stimulation

Due to its safety and ease of use, Sooma tDCS can be a viable tool for remote supervised trials. The safety of self-administered treatment with Sooma tDCS has been confirmed in clinical studies.

The first session should always be done under the supervision of a researcher or clinician. During this session, the patient’s ability to perform self-administered stimulation is assessed. After the first session, the treatment device can be lent to the patient in the trial for the rest of the stimulation sessions. If practical, the patient can take pictures of treatment preparations to ensure that self-administered treatment has been done as per the trial guidelines. The device counts the number of treatments done, so that the researcher or physician can ensure correct use frequency. After the acute phase, the device is returned to the university or clinic. The device can also be set to lock itself from further use after a set amount of treatments to prevent overuse.

Sooma tDCS and Sooma head caps can be configured for a multitude of research protocols. The system can be ordered with the desired protocol or the system can be delivered with a special tool that allows on-site configuration. Please note that use of research protocols is investigational use and may require IRB approval.

View our brochure for additional product information
Health Canada License Number

Depression therapy with Sooma tDCS*

Sooma Depression Therapy is suitable for most patients. It can be added to ongoing treatments without modifications, and it has been shown to have additive effects to both medication and psychotherapy. Sooma Depression Therapy can also be used as a stand-alone treatment, and as such is also a viable option for patients who cannot tolerate pharmaceutical treatment options.

A treatment session consists of 2 mA direct current stimulation for 30 minutes. This procedure is programmed as the standard treatment protocol in the Sooma tDCS™ unit. The full depression treatment consists of 5 treatment sessions per week for 2-3 weeks, followed by maintenance treatments.

Sooma tDCS Depression Therapy

Provide fast depression care without compromises

Sooma Depression Therapy offers effective depression relief in just three weeks. The therapy uses non-invasive brain stimulation to modulate neuronal activation in the frontal areas of the brain. 84% of patients complete their treatment course successfully and the majority get help as a result. The effect size in randomized controlled trials is shown to be similar to antidepressant pharmaceuticals. The therapy is not associated with serious or systemic side effects. As such, the therapy is safe during breastfeeding and the patient can even self-administer the treatment at home.

What is Sooma Depression Therapy?

Sooma Depression Therapy uses non-invasive brain stimulation to modulate the function of prefrontal areas of the brain. A portable medical device delivers electrical current to the brain for 30-minutes at a time. The aim is to normalise the hypoactivity of the left dorsolateral prefrontal cortex (DLPFC). After repeating the stimulation once a day for three weeks, symptoms are relieved for the majority of patients. Sooma Depression Therapy is not associated with serious or systemic side effects. It is also painless and safe to self-administer by the patient.

Simple neuromodulation therapy

Sooma Depression Therapy is an effective and well-tolerated tool for depression care. It uses a weak electrical current to modulate the function of the brain. The current is delivered non-invasively through two electrodes placed on the scalp: the current goes in through the positive electrode, an anode, and returns via the negative electrode, a cathode. A session lasts for 30-minutes and is repeated once every weekday for three weeks. Repeated sessions are required to achieve behavioural effects and relief from depressive symptoms, but the effects of even a single session can be measured by neurophysiology or by metabolic imaging.

The electrode placement is critical to the success of the therapy. We use an intuitive head cap to enable reproducible electrode placement to targeted locations on the scalp. The excitatory stimulation is delivered to the left dorsolateral prefrontal cortex in order to increase neuronal activation in the area. The inhibitory stimulation is targeted to the right dorsolateral prefrontal cortex with the aim of suppressing hyperactivity in the area. Consequently, the imbalance between brain hemispheres, that is also typical in major depressive disorder, is normalised.

Sooma tDCS DLPFC

In the above figure, the anode is placed over the left DLPFC and the cathode electrode is positioned over the right DLPFC.

Sooma tDCS for Depression

Easy to apply

The stimulation is delivered using a Class IIa-medical device: Sooma tDCS. The stimulator unit is indicated for the treatment of depression and chronic pain. As such, users are covered by a liability insurance when applying stimulation with Sooma tDCS to these indications. Sooma tDCS features a single control button that is used to start and pause the stimulation. Everything else is automated for your convenience and to prevent accidental modification of stimulation output. The stimulator unit is portable enabling normal movement during stimulation. Consequently, the stimulation can be done while reading a book, walking a dog, doing office work etc.

Sooma Depression Therapy

A physician is able to follow the progress of the home-based patients during Sooma Depression Therapy via Sooma Software Suite. An application is installed on the patient’s mobile phone, which is used to record data about mood and wellbeing. The data is synchronised to a cloud which the physician is able to access via an internet browser. Using the data, the physician is able to monitor the treatment progress and make instant changes to the treatment schedule. Access to Sooma Software Suite is included in Sooma Depression Therapy.

Sooma Home Monitoring Depression Therapy

Fast, safe and effective

Sooma Depression Therapy is extremely well tolerated and not associated with serious adverse events. 84% of patients complete the treatment course successfully even if they are required to visit a clinic for every treatment session. A recent safety review, based on over 40 000 stimulation sessions, concluded that the technique is safe even when used in adolescent or elderly population. Typical side effects include itching under the electrodes during stimulation and a transient headache after the stimulation. FDA has concluded the stimulation to be without a reasonable expectation of any serious adverse event, a stance that has been adopted also by NICE and the Royal College of Psychiatrists.

Majority of patients undergoing Sooma Depression Treatment show significant depression improvement after two weeks. The Royal College of Psychiatrists has released a supportive statement about tDCS on depression treatment. The European evidence-based guideline concluded with a level B (probable efficacy) recommendation and even the National Institute of Care Excellence has issued a guidance on the technique. After the therapy, most patients continue with some form of treatment to prevent new onset of depression.

The therapy can be safely chosen already as a first treatment option. There are no chemical agents involved that would affect the whole body. The therapy can be added-on to ongoing therapies without a risk of dangerous drug interactions. It is also safe to breastfeed when undergoing the treatment.

Consumption of nicotine and alcohol should be avoided during the therapy to ensure optimal efficiency. Contraindications for the therapy are metal implants within the skull, pacemaker, head area surgery within the last 6 months, and acute eczema in the stimulation area.

The safety profile of tDCS is very good throughout all of the studies. No study has reported any serious adverse events associated with tDCS. Typical side effects include itching under the electrodes during stimulation and a transient headache. Notably, the side effect profile is different from antidepressant medication and as such, tDCS may be considered as an alternative for patients who have difficulties with medication side effects. None of the meta-analyses reported no difference between active and sham groups in safety and acceptability

* In the USA, tDCS is labeled as investigational. Sooma tDCS is limited by Federal (or US) law to investigational use by researchers or medical doctors. This device is not cleared for medical treatment in the USA. In the EU, Sooma tDCS is a class IIa medical device CE approved for treatment of Major Depressive Disorder, Fibromyalgia, and Neuropathic pain.

Pain therapy with Sooma tDCS*

Sooma Pain Therapy is intended for patients suffering from chronic pain conditions such as Fibromyalgia and chronic Neuropathic pain. It is suitable for most patients, and can be added to ongoing pharmaceutical treatments without modifications. Sooma Pain Therapy can also be used as a stand-alone treatment, and as such is also a viable option for patients who cannot tolerate pharmaceutical treatment options.

A treatment session consists of 2 mA direct current stimulation for 20 minutes. This procedure is programmed a standard treatment protocol in the Sooma tDCS™ unit. The full pain treatment consists of 5 treatment sessions per week for 2 weeks.

Transcranial direct current stimulation is a form of low-intensity electrical stimulation. There are no medical preparations needed for the treatment. The patient should remove eye-glasses, hair pins and jewellery from the head area, and restrain from using hair gel or hair spray before treatment session.

Sooma tDCS Pain Therapy

Offer an effective, opioid-free pain relief to your patients

Sooma Pain Therapy offers an effective pain relief and helps to reduce analgesic use. This is done by modulating the sensory and affective processing of pain using non-invasive brain stimulation. Recent meta-analyses show up to 58% pain relief for Fibromyalgia in just two weeks and significant quality of life improvement for patients suffering from chronic neuropathic pain. Applying the therapy is easy and a patient can also self-administer the therapy at home.

What is Sooma Pain Therapy?

Sooma Pain Therapy is a non-invasive neuromodulation treatment course. During the therapy, the brain network involved in pain processing is stimulated repeatedly to achieve pain relief. A portable medical device is used to deliver a weak electrical current through the scalp to the brain. A treatment session lasts for 20-minutes and it is repeated once a day for two weeks to achieve a therapeutic response. The therapy is prescribed by a physician but the treatment sessions can be administered at home. The treatment is painless and the patient may continue with regular activities after the session.

How does Sooma Pain Therapy work?

Sooma tDCS for pain electrode placement

Sooma Pain Therapy uses a low electrical current to modulate the function of the brain. The current is delivered non-invasively through two electrodes placed on the scalp: the current goes in through the positive electrode, an anode, and out via the negative electrode, a cathode. A session lasts for 20-minutes and is repeated once a day for two weeks. Repeated sessions are required to achieve behavioural effects and pain relief, but the effects of even a single session can be measured via MEP, MEG, TMS-EEG, fMRI and epidural electrode. Adherence to all treatment sessions is important for optimal pain relief.

The placement of electrodes is critical to the success of the therapy. As such, we use an intuitive head cap that enables a reproducible electrode placement to targeted locations on the scalp. The excitatory stimulation is delivered to the motor area, while the contralateral supraorbital area undergoes inhibitory stimulation. The side of excitatory stimulation is governed by (a) handedness and (b) pain origin so that the anode is positioned over the dominant hemisphere or contralaterally to the side of local pain as demonstrated in Figure 1.

Motor cortex stimulation is thought to influence pain processing through activation of neural networks in the precentral gyrus. These networks connect structures that are involved in different components of pain such as the emotional and sensory processing of pain. It has also been proposed that motor cortex stimulation facilitates the function of descending pain inhibitory controls.

Who is best suited for the Therapy?

Sooma Pain Therapy is intended for patients suffering from chronic pain such as Fibromyalgia and chronic neuropathic pain. The patient may undergo simultaneous treatments, to which Sooma Pain Therapy is added on. A patient needs a prescription in order to receive Sooma Pain Therapy.

A wide variety of healthcare service providers may benefit from Sooma Pain Therapy. The therapy is well-suited as a first line treatment delivered by a primary care physician or a family doctor. Moreover, Sooma Pain Therapy can add significant value to the toolbox of a university hospital.

* In the USA, tDCS is labeled as investigational. Sooma tDCS is limited by Federal (or US) law to investigational use by researchers or medical doctors. This device is not cleared for medical treatment in the USA. In the EU, Sooma tDCS is a class IIa medical device CE approved for treatment of Major Depressive Disorder, Fibromyalgia, and Neuropathic pain.

Enabling effective home-based tDCS with remote monitoring*

With Sooma’s new software suite, a mobile app for patients and an internet portal for clinicians, effective home-based tDCS-treatment is finally possible. The app ensures that patients perform the treatment correctly and comply with their treatment schedule and clinicians can monitor patient progress remotely using the browser-based Sooma Professionals’ Center.

The software suite is for now included at no extra cost when you purchase a Sooma tDCS device. Users already using Sooma tDCS should contact Sooma to get access to and learn how to start using the software suite.

Sooma tDCS enables you to scale up your research with home-based, self-administered use.

Sooma Home tDCS Mobile Portal

Benefits for medical professionals:

  • Enables home-based, self-administered tDCS. Only the first session is done at your clinic.
  • Ensures patient compliance
  • Monitor your patients’ treatment progress
  • Save time and money by reducing patient visits while still ensuring just as effective treatment!

Benefits for patients:

  • Save time – one tDCS session instead of 10-15 are done at the clinic
  • Treatment reminders make sure you take the treatment as per your doctor’s prescription
  • Step-by-step instructions for applying the treatment in case you need it
  • Log your well-being daily, identify trends and quantify your treatment progress

How it works

Create a treatment schedule and monitor your patient’s progress using Mood, Activity, Sleep, and Appetite, Step Count, and other wellbeing variables you want to measure. You can choose to use the portal using any workflow that suits you. For example, you can get into a routine of checking all your patients in the portal in 15 minutes twice a week. If needed, you may decide to contact the patient (for example if they seem to be in remission) or change the patient’s treatment schedule (for example if they seem to need another week to gain the full benefits of the treatment). Over time you will be able to gather data that you can use to further optimise and improve things like patient and treatment protocol selection

The first session should always be done under the supervision of a clinician. During this session, the patient’s ability to perform self-administered stimulation is assessed. After the first session, the treatment device is lent to the patient for the acute treatment phase. The Sooma Depression Therapy Pro app contains step-by-step instructions so the patient can ensure that they are using the device correctly. The device can also be set to lock itself from further use after a set amount of treatments to prevent overuse.

* In the USA, tDCS is labeled as investigational. Sooma tDCS is limited by Federal (or US) law to investigational use by researchers or medical doctors. This device is not cleared for medical treatment in the USA. In the EU, Sooma tDCS is a class IIa medical device CE approved for treatment of Major Depressive Disorder, Fibromyalgia, and Neuropathic pain.

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