Summation
- The study, which was presented in poster format at the Annual Meeting of the Clinical TMS Society's (CTMSS) and the American Psychiatric Association (APA) annual meetings, identified improvement in the active Deep TMS group versus the sham group at week five and at week 16.
- Considering the high prevalence and disease burden of depression, researchers at BrainsWay and Ben Gurion University sought to shed light on the impact of quality of life for treatment-resistant depression patients following Deep Transcranial Magnetic Stimulation (Deep TMS™) therapy.
- A widely replicated finding in medication and psychotherapy studies is that although the treatments are superior to placebo at reducing depressive symptoms, they are no better than placebo when assessing improvements in quality of life.
Major depressive disorder (‘MDD’ or depression) is the leading cause of disability globally, affecting nearly 350 million people worldwide. It is well known that MDD substantially impacts quality of life. Yet, much less is known about how treatments for depression impact quality of life.
Most depression assessments focus on symptom reduction, with clinicians commonly using scales like the Hamilton Depression Rating Scale to evaluate outcomes. These scales measure the deficits from depression, including suicidality, difficulties with sleep, work, sadness, worry, physical complaints, appetite etc. However, the resolution of those deficits does not necessarily translate into a positive quality of life. This includes actual satisfaction or enjoyment in those same domains that had been impaired, and in other areas such as relationships and leisure activities that are not assessed in the scales. For example, a previously depressed patient may no longer be suicidal and is sleeping and eating normally, but they will have suboptimal functioning in various areas that put them at risk of relapsing.
The most commonly used treatments for depression are medications, which are studied against placebo. A widely replicated finding in medication and psychotherapy studies is that although the treatments are superior to placebo at reducing depressive symptoms, they are no better than placebo when assessing improvements in quality of life. The hypothesis is that when depressed patients’ quality of life improves, it is due to the placebo response (i.e. the expectation of getting better and natural healing response) rather than the drug or psychotherapy.
This limitation of drugs and therapy to address patients’ quality of life is one reason why patients are referred for combined psychotherapy and pharmacotherapy.
The Effect of Deep TMS on Quality of Life
Considering the high prevalence and disease burden of depression, researchers at BrainsWay and Ben Gurion University sought to shed light on the impact of quality of life for treatment-resistant depression patients following Deep Transcranial Magnetic Stimulation (Deep TMS™) therapy. They measured the effect of Deep TMS treatment on both symptom reduction and reported quality of life.
Deep TMS is a newer technology allowing nonsurgical stimulation of relatively deep brain areas, which has been shown to be effective in the treatment of patients with treatment-resistant depression. The H1 Coil stimulates the bilateral prefrontal cortex with a left preference, stimulating neurons over three centimeters from the coil to modulate the neural activity of brain structures related to MDD.
The Results of the Deep TMS and Depression Research Study
Using data on 181 patients from the Deep TMS sham-controlled twenty-center trial in treatment-resistant MDD, researchers investigated the effect of Deep TMS treatment on quality of life. All the patients had their antidepressants discontinued several weeks prior to starting the treatments. The treatment protocol consisted of five Deep TMS sessions per week for four weeks (the acute treatment phase), followed by 12 weeks of two sessions per week (the continuation/maintenance phase). Quality of life was measured using the Quality-of-Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). This rating scale asks patients about their satisfaction level from the past week with some of the following: health, mood, work, household, family, social, leisure time, sex, hobbies, economics, and more.
The study, which was presented in poster format at the Annual Meeting of the Clinical TMS Society’s (CTMSS) and the American Psychiatric Association (APA) annual meetings, identified improvement in the active Deep TMS group versus the sham group at week five and at week 16.
The results showed that at week five, the active Deep TMS group improved significantly in quality of life compared to sham. Not surprisingly, there was a correlation between the extent of improvement in quality of life and the extent of depressive symptom improvement. To be more specific, responders – those who showed greater than a 50% decrease in their Hamilton Depression Rating Scale score from baseline – demonstrated a significantly larger improvement in reported quality of life (133%) compared with non-responders (25%).
At week 16, 59% of the patients who showed improvement in Q-LES-Q scores from baseline at week five sustained their improvement or improved further.
This is an important finding because low quality of life is a potent and intransigent factor that contributes to the global disability associated with depression. It relates to the concept of recovery from illness, not just response and remission. We know that patients need to get beyond the minus zone of depression and enter the plus zone of productive life to fully engage with family and society. Any residual symptoms, which may be within normal limits on depression symptom rating scales but evident on quality of life scales, put patients at risk of relapse. If someone is improving in quality of life then they are lower risk of disability and relapse.
Is Deep TMS Therapy for Depression a Viable Option?
Since Deep TMS is a more burdensome treatment than medication, requiring the patient to come into the office daily for several weeks, there has to be added value for the patient to choose that treatment. It is usually reserved for patients who previously failed medications – because three out of four medication-resistant patients will respond to Deep TMS. Alternatively, medications may cause systemic side effects and TMS rarely has systemic side effects. This study demonstrates an additional reason to utilize Deep TMS to treat deficits in quality of life and enjoyment. This method is worth the extra effort beyond staying home and taking medication.
If we can improve symptoms and quality of life for those suffering from depression, we can not only improve the overall health of nearly 350 million people worldwide, we can also reduce their risk of relapse and decrease the incidence of disability caused by MDD.
Dr. Aron Tendler, M.D., is the chief medical officer of BrainsWay, a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. BrainsWay is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. Dr. Tendler has been a practicing clinical psychiatrist for nearly two decades.
