Product

Product2018-10-04T09:07:44+00:00

Sooma tDCS™

Using mild and non-invasive neuromodulation, Sooma tDCS™ adds a new dimension to the clinical routine for treating patients with major depression or chronic pain.

  • Safe and well tolerated
  • Effective
  • Easy to use, designed for clinical routine
  • Affordable and cost-effective
  • Can be used as monotherapy or as adjunct to other treatments

Sooma tDCS™ delivery kit includes all you need to get started with depression therapy or pain therapy.

Please note that Sooma tDCS is sold only to medical professionals. If you are a patient wishing to receive tDCS treatment, please inquire your physician about the possibility.

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

Sooma tDCS™ is a class IIa medical device CE approved 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 treatment 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. Contact us to learn more about research co-operation. Please note that research use is investigational and may require ethical committee approval.

For a detailed product overview, see our brochure and our white paper.

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.

Treatment Protocol Depression Therapy

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.

Treatment protocol

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.

Treatment session

When starting a session, two electrodes are positioned over the treatment 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 left and right dorsolateral prefrontal cortex (DLPFC) for depression treatment, and to the scalp at the motor cortex for pain treatment, with the placement depending on the location of the pain and on the handedness of the patient. The current intensity is 2 mA, which is 400 to 500 times less than in traditional electroconvulsive therapy.

During the session, the patient is fully awake and alert. Simultaneous psychotherapy, occupational therapy or even group therapy can be administered during the 30 or 20 minute stimulation period, or the patient can relax and read a book or watch television.

Safety

No deaths, seizures or memory loss have been associated with tDCS in over 40 000 stimulation sessions.

tDCS has mostly been used for adult population, but in their comprehensive review, Palm U, et al concluded that tDCS seems to be safe for pediatric population as well. Bikson M, et al, in their safety review based on over 40 000 stimulation sessions, concluded that the technique is safe even when used in adolescent or elderly population. The method is well tolerated and not associated with serious side-effects or withdrawal effects.

Sooma provides training for new users. For more details on safety, see the ‘Safety’ section on the Science-page.

Efficacy

tDCS has been shown to significantly reduce depression symptoms and bring clinically meaningful results. The effect size is estimated to be similar to antidepressant medication in primary care. Most investigated patient group is adults with moderate to severe depression. Due to its safety, tDCS can also be a viable tool for early intervention in depression.

More detailed information on clinical research and efficacy on depression can be found on the Science-page.

tDCS has also been shown to reduce symptoms of pain. The method has been used to treat various pain types across several hundred scientific publications and clinical trials which have seen significant results.

Use in home healthcare environment

The safety of self-administered treatment with Sooma tDCS has been confirmed in clinical studies (Hyvärinen 2016).

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. If practical, the patient can take pictures of treatment preparations to allow his physician to ensure that self-administered treatment has been done correctly. The device counts the number of treatments done, so that the physician can ensure correct use frequency.

After the acute phase, the device is returned to the clinic, and the patient visits the clinic normally for maintenance treatments.

The device can also be set to lock itself from further use after a set amount of treatments to prevent overuse.

Research use

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 ethical committee approval.

We would be happy to help in devising your research protocol and setup. Please contact us for research support.

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