Sooma tDCS Device Features 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 Device 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 informationHealth Canada License Number
