Sooma tDCS Pain Therapy Device
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 stimulation¹. Recent meta-analyses show up to 58% pain relief for Fibromyalgia in just two weeks² and significant quality of life improvement for patients suffering from chronic neuropathic pain³. Applying the therapy is easy and a patient can also self-administer the therapy at home.
Up to 58% pain relief persisting 2 months after the end of treatment2
59% reduction in post-surgery opioid use5
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.
We feel that everyone deserves a high quality care. Sooma Pain Therapy provides an effective tool for management of pain that is also accessible by primary care and family doctors. Offer your patients pain relief without fear of addiction. Treat patients, who are unable to visit the clinic, efficiently without compromising safety.
How does Sooma pain treatment work?
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 MEP6, MEG7, TMS-EEG8, fMRI9 and epidural electrode10. 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.
Figure 1. Electrodes placement in Sooma Pain Therapy is dependant on (a) handedness and (b) pain origin.
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 controls15,16.
What does the Therapy involve?
Figure 2. Sooma Pain Therapy utilises a small portable medical device called Sooma tDCS. The system consists of a stimulator unit, two electrodes with colour-coded cables, a head cap for electrode positioning and a stimulation pad that forms the contact surface between a patient and the electrode.
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, its 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, including ending a session, 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.
Figure 3. Sooma Software Suite may be used to monitor a patient during Sooma Depression Therapy. The patient records their mood and well-being information daily using a mobile application.
A physician is able to follow the progress of home-based patients during Sooma Pain Therapy via Sooma Software Suite. An application is installed on the patient’s mobile phone, which is used to record data about wellbeing and daily levels of pain. The data is synchronised to a cloud which the physician is able to access via internet browser. Using the data, the physician is able to monitor the treatment progress and make instant changes to treatment schedule. Access to Sooma Software Suite is included in Sooma Pain Therapy.
Who is best suited for the Pain 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.
What are the risks of tDCS treatment?
Sooma Pain Therapy is 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 population4. Typical side effects include itching under the electrodes during stimulation and a transient headache after the stimulation. FDA views the stimulation to be without a reasonable expectation of any serious adverse event4, a stance that has been adopted also by NICE11 and the Royal College of Psychiatrists12.
No dangerous interactions with pharmaceuticals have been reported4. 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, a pacemaker, head area surgery within the last 6 months, and acute eczema in the stimulation area.
How effective is this kind of pain treatment?
The technique has been utilised in various pain types across several hundred scientific publications and clinical trials. European Academy of Neurology (EAN) gave a weak recommendation to the technique in the treatment of chronic neuropathic pain in 2016³. In the European evidence-based guideline, a recommendation is given also for the treatment of Fibromyalgia¹.
The meta-analysis conducted by Zhu et al. concluded that tDCS over M1 improves general fibromyalgia related functions compared to baseline (SMD -0.59, p=0.0002)2. Meta-analysis of chronic neuropathic pain related to spinal cord injury found more pain relief after active tDCS versus placebo (SMD 0.510, p<0.012)13. In a post-operative setting, Brockardt et al. reported a reduction of patient-controlled analgesia hydromorphone from 12.3 mg in the placebo group to 6.6 mg in tDCS group (p=0.006)14. The results were replicated by Khedr et al, who reported 59% reduction in titrated analgesia after just 4 stimulations for the active tDCS group (p=0.0001)5.
Figure 2. Patient-controlled analgesia was significantly lower in active tDCS group in a study by Brockard et al. Further, Kherd et al found that anaesthesiologist titrated analgesia was significantly lower in active tDCS group versus placebo.
Availability of Sooma Pain Therapy
Sooma Pain Therapy is available worldwide through a wide network of local partners. It has CE and Health Canada approvals among others. See your local Sooma distributor here.
- Lefaucheur JP et al. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation(tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92.
- Zhu CE et al. Effiectiveness and safety of transcranial direct current stimulation in fibromyalgia: A systematic review and meta-analysis. J Rehabil Med. 2017 Jan 19;49(1):2-9.
- Cruccu G et al. EAN guidelines on central neurostimulation therapy in chronic pain conditions. Eur J Neurol. 2016 Oct;23(10):1489-99.
- Bikson M, et al. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-61.
- Khedr EM, et al. Role of transcranial direct current stimulation on reduction of postsurgical opioid consumption and pain in total knee arthroplasty: Double randomized clinical trial. Eur J Pain. 2017 Sep;21(8):1355-1365.
- Nitsche MA ja Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3:633-9.
- Pellegrino et al. Bilateral Transcranial Direct Current Stimulation Reshapes Resting-State Brain Networks: A Magnetoencephalography Assessment. Neural Plasticity, vol. 2018, Article ID 2782804, 10 pages, 2018.
- Romero Lauro et al. TDCS increases cortical excitability: direct evidence from TMS-EEG. Cortex. 2014 Sep;58:99-111.
- Keeser D et al. Prefrontal Transcranial Direct Current Stimulation Changes Connectivity of Resting-State Networks during fMRI. Journal of Neuroscience 26 October 2011, 31 (43) 15284-15293
- Di Lazzaro V et al. Transcranial Direct Current Stimulation Effects on the Excitability of Corticospinal Axons of the Human Cerebral Cortex. Brain Stimulation 6 (2013) 641-643
- National Institute of Care Excellence – Interventional guidance IPG530 (2015) Available online: https://www.nice.org.uk/guidance/ipg530
- The Royal College of Psychiatrists – Position statement CERT04/17 (2017) Available online: http://www.rcpsych.ac.uk/pdf/Transcranial%20direct%20current%20stimulation%20-%20ECT%20ctee%20statement%20Feb%2017.pdf
- Mehta S et al. Effectiveness of transcranial direct current stimulation for the management of neuropathic pain after spinal cord injury: a meta-analysis. Spinal Cord. 2015 Nov;53(11):780-5.
- Borckardt JJ, et al. Transcranial direct current stimulation (tDCS) reduces postsurgical opioid consumption in total knee arthroplasty (TKA). Clin J Pain. 2013 Nov;29(11):925-8.
- Lefaucheur JP, et al. Somatotopic organization of the analgesic effects of motor cortex rTMS in neuropathic pain. Neurology. 2006 Dec 12;67(11):1998-2004.
- Nguyen JP, et al. Invasive brain stimulation for the treatment of neuropathic pain. Nat Rev Neurol. 2011 Sep 20;7(12):699-709