Sooma Depression Therapy Device
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 result1. The effect size in randomized controlled trials is shown to be similar to antidepressant pharmaceuticals2. The therapy is not associated with serious or systemic side effects3. As such, the therapy is safe during breastfeeding and the patient can even self-administer the treatment at home.
84% of patients complete their treatment course successfully
Up to 59% of patients gain treatment response in three weeks
Sooma Treatment Outcomes. N= 227. Scale: HAMD or MADRS
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 patients1. Sooma Depression Therapy is not associated with serious or systemic side effects. It is also painless and safe to self-administer by the patient.
“My patient’s mood was significantly better already during the second treatment week. Treatment also positively affected sensations of pain and anxiety”
Psychotherapist of a moderately-depressed patient who achieved a treatment response
We feel that everyone deserves a high quality care. Sooma Depression Therapy provides an effective tool for depression care that is also accessible by primary care and family doctors. Offer fast and effective depression relief to your patients without fear of systemic side effects.
Depression treatment with 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.
Figure 1. Left: The anode is placed over the left DLPFC and the cathode electrode is positioned over the right DLPFC. Right: The therapy is easy to administer and a patient is free to engage in various activities during the session.
Easy to apply depression treatment device
Figure 2. Sooma Depression 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, 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.
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 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.
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 session1. A recent safety review, based on over 40 000 stimulation sessions, concluded that the technique is safe even when used in adolescent or elderly population3. 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 event3, a stance that has been adopted also by NICE9 and the Royal College of Psychiatrists10.
Majority of patients undergoing Sooma Depression Treatment show significant depression improvement after two weeks1. The Royal College of Psychiatrists has released a supportive statement about tDCS on depression treatment10. The European evidence-based guideline concluded with a level B (probable efficacy) recommendation21 and even the National Institute of Care Excellence has issued a guidance on the technique9. 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.
Figure 4. A Physician can easily monitor the progress of a patient via a web portal.
The technique, transcranial direct current stimulation, has been shown to be an effective treatment for major depressive disorder. The effectiveness has been demonstrated in multiple placebo-controlled studies and recently also in studies with large sample sizes. A meta-analysis of individual patient data indicated effectiveness similar to rTMS and antidepressant medication3. Further, an analysis of the predictors of clinical response showed that a high degree of treatment-resistance is negatively associated with the response. This finding should be considered during patient selection.
The Royal College of Psychiatrists has released a supportive statement about tDCS on depression treatment10. The European evidence-based guideline concluded with a level B (probable efficacy) recommendation21 and even the National Institute of Care Excellence has issued a guidance on the technique9. 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. It can be used as monotherapy or added to ongoing therapies without a risk of dangerous drug interactions.
There is high-level evidence of the therapeutic effects of tDCS after repeated sessions. Most recently, Brunoni et al. published a study of 245 patients in New England Journal of Medicine, where tDCS was dominant to sham. Reported response rates using MADRS scale were 40% and 23% for tDCS and sham respectively12. In 2017, Valiengo et al. and Salehinejad et al. published further results supporting the efficacy of depression treatment13,14. Including publications prior to 2017, the meta-analysis of individual patient data concluded tDCS to be significantly superior to sham for the response, the remission and the depression improvement. Response rates were 34% and 19% for tDCS and sham respectively (OR=2.44, 95%, CI 1.38-4.32, NNT=7)2. Interestingly, the combination of SSRI medication and tDCS has been shown to be more effective than either of the interventions alone22. As such, add-on tDCS could help sensitive patients to achieve a treatment response with a lower dose of medication.
Figure 5. In a study of 120 patients by Brunoni et al, the combination of sertraline and tDCS was found to be more effective than either of the interventions alone. Response rates were 16.7% for placebo+sham group, 33.3% for sertraline+sham group, 43.3% for placebo+tDCS group and 63.3% for sertraline+tDCS group.
In the field of bipolar depression, a meta-analysis by Donde et al.15 concluded that depression scores decreased significantly with medium effect size after active tDCS (SMD 0.71, z=3.00, p=0.003). Sampaio-Junior et al.16 published further results in 2017, concluding that response rates were higher in the tDCS group than the sham group (67.6% vs 30.4%, NNT 2.69; 95% CI, 1.84-4.99; p=0.01).
More than a thousand patients have undergone Sooma Depression Therapy since 2014. We periodically update our database of reported treatment outcomes and release it unfiltered on our blog. The outcome data reflect how the treatment is applied in clinical practice today. Moreover, it shows what can be realistically expected as a treatment outcome.
Based on the results, the majority of patients get significant help from the therapy. Currently, 59% of patients show a treatment response, a reduction of over 50% in their depression score. Aside from mood improvement, a decrease in anxiety level is commonly seen in patients. Several patients have also reported increased activity and better functionality in daily life. Normalised appetite and sleep patterns have also been among the effects reported.
Figure 5. 59% of patients respond to Sooma Depression Therapy and gain significant relief from depressive symptoms.
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 acceptability2,17,18.
Brunoni et al have performed a systematic review of adverse events and adverse reactions to transcranial direct current stimulation (tDCS) in 209 studies across multiple clinical and non-clinical indications19. Mild side effects, such as itching and tingling, are fairly common (reported by 30-40 % of the studies), while a headache and burning sensation in the skin are observed less frequently (reported by 10-15% of the studies). Side effects related to skin irritation can be minimised by using saline solution as a conductive agent. Sooma Therapies use 0.9% NaCl solution as the conductive agent. Finally, animal studies have shown that current densities of the magnitude used in human trials do not cause tissue damage20. Current density thresholds for causing tissue damage are about one hundred times bigger than those used in human clinical trials and Sooma therapies.
- Sooma – Treatment Outcomes (2018) Available online: https://soomamedical.com/blog/new-and-updated-outcomes-for-sooma-depression-therapy/
- Brunoni et al. Transcranial direct current stimulation for acute major depressive episodes: meta-analysis of individual patient data. The British Journal of Psychiatry (2016) 208, 1–10
- Bikson M, et al. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-61.
- 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
- Horvath JC et al. Quantitative Review Finds No Evidence of Cognitive Effects in Healthy Populations From Single-session Transcranial Direct Current Stimulation (tDCS). Brain Stimul. 2015 May-Jun;8(3):535-50
- Brunoni et al. Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression. N Engl J Med 2017; 376:2523-2533
- Valiengo LC et al. Transcranial direct current stimulation for the treatment of post-stroke depression: results from a randomised, sham-controlled, double-blinded trial. J Neurol Neurosurg Psychiatry. 2017 Feb;88(2):170-175.
- Salehinejad MA et al. Cognitive control dysfunction in emotion dysregulation and psychopathology of major depression (MD): Evidence from transcranial brain stimulation of the dorsolateral prefrontal cortex (DLPFC). J Affect Disord. 2017 Mar 1;210:241-248.
- Donde C et al. Transcranial direct-current stimulation (tDCS) for bipolar depression: A systematic review and meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Aug 1;78:123-131.
- Sampaio-Junior B et al. Efficacy and Safety of Transcranial Direct Current Stimulation as an Add-on Treatment for Bipolar Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Feb 1;75(2):158-166.
- Shiozawa P et al. Transcranial direct current stimulation for major depression: an updated systematic review and meta-analysis. Int J Neuropsychopharmacol. 2014 Sep;17(9):1443-52
- Meron D et al. Transcranial direct current stimulation (tDCS) in the treatment of depression: Systematic reviewand meta-analysis of efficacy and tolerability. Neurosci Biobehav Rev. 2015 Oct;57:46-62.
- Brunoni AR et al. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45.
- Liebetanz D et al. Safety limits of cathodal transcranial direct current stimulation in rats. Clin Neurophysiol. 2009 Jun;120(6):1161-7.
- 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.
- Brunoni et al. The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial. JAMA Psychiatry. 2013;70(4):383-391