TMS Registry to Examine Real-World Efficacy in Major Depression

Liam Davenport

November 25, 2016

A registry to gather data on the transcranial magnetic stimulation (TMS) therapy in thousands of patients with major depressive disorder (MDD) has been established to further understanding of this promising technique.

NeuroStar Advanced Therapy (NAT; Neuronetics) is a noninvasive treatment that induces an electric current within the cerebral cortex via MRI-strength pulsed magnetic fields.

The registry, which will be the largest in patients treated with TMS, will attempt to show the real-world performance of NAT in the clinical setting and demonstrate its long-term durability, using validated reporting tools.

As previously reported by Medscape Medical News, TMS has been shown to provide long-lasting relief of antidepressant-resistant MDD and to significantly improve patients' quality of life and functional status.

Moreover, an economic analysis of the NeuroStar system, which was approved by the US Food and Drug Administration in October 2008 for the treatment of antidepressant-resistant MDD, showed that it is a cost-effective treatment option in comparison with drug therapy.

"In the long term, the research obtained from this registry has the potential to change the way we provide care to people with chronic depression," Kenneth P. Pages, MD, medical director, TMS of South Tampa, Florida, who will be taking part in the registry, said in a release. "The information collected over the years will equip physicians with case histories and the necessary research to tailor the most effective treatment plans. This, in turn, will allow us to better understand and ultimately meet the needs of these patients."

A Welcome Addition

Approached for comment, David Feifel, MD, PhD, professor, Department of Psychiatry and Department of Neurosciences, University of California, San Diego, and founding director, University of California, San Diego, Center for Advanced Treatment of Mood and Anxiety Disorders, welcomed the establishment of the registry.

"Randomized controlled trials are a great way of learning about treatments and evaluating them. Absolutely they remain the gold standard, but there's a lot of knowledge to be extracted from real-world clinical practice," he told Medscape Medical News.

"The problem has always been is that any one practitioner sees a limited number of patients and...that can be very nonrepresentative. What a registry does, when there's an opportunity, is it aggregates the experience of hundreds, sometimes thousands, of clinicians as they are using the treatment in the real world, and there's a lot of power to that."

The registry, which was launched by NeuroStar on November 21, was established to collect and analyze data from patients with MDD treated with NAT, with the aim of gathering data on more than 6000 patients from at least 100 of the currently more than 740 NeuroStar providers across the United States.

Specifically, the registry with collect information on the patients' age, sex, and diagnosis, and the specifics of their treatment with NAT, such as the number of pulses they received, on which side of the brain, and the total dose received. Disease outcomes after treatment will be reported using validated clinical rating scales.

The intention is that the total number of patients enrolled on the registry will eventually exceed that for the Sequenced Treatment Alternatives to Relieve Depression collaborative study, which was funded by the National Institute of Mental Health.

Reimbursement Issues

Dr Pages told Medscape Medical News that the published literature on NeuroStar TMS is based on studies that were very well controlled and typically homogeneous. As a consequence, the registry "is really an opportunity for us to see whether what we're doing in practice holds up to the published data results."

He continued that the registry will help with "tailoring the treatments that we're giving based on more evidence-based medicine than what we're doing now, which is largely our anecdotal clinical experience."

With more data on TMS, such as from this registry, Dr Pages expects that eventually the therapy will be used much earlier in the treatment of depression than it is now.

He noted that at this time, patients "depend on their insurance coverage to be able to have TMS, but the insurers usually put a somewhat high hurdle." This means that patients have to have failed four medications, including one combination treatment.

"We're talking about patients who have been ill for a long period of time and are more resistant than what is defined as treatment-resistant depression, which is usually that you fail two tests," he said.

Dr Pages pointed out that, as a consequence, it is currently unknown whether patients who have relatively less treatment resistance will respond better to TMS.

"If that's the case, it would argue that we should be offering TMS earlier, not just because it could possibly help patients to suffer less or a less period of time, but also that we're more likely to get them better," he said.

Dr Feifel agreed with Dr Pages that the patient population receiving TMS is relatively small, "and that is mostly a factor of the reimbursement here in the United States. The insurance companies like to stick very closely to the most rigorous level of evidence and what is approved by the [US Food and Drug Administration]."

Effective for Other Conditions?

"We have very strong reasons to suspect that this is effective for a much, much wider population and not only types of depression like bipolar depression and patients who have less levels of failure, but also there's going to be, in the next 2 decades, an explosion in the indications that we use TMS for," he added.

This will include obsessive–compulsive disorder, posttraumatic stress disorder, addiction, and neurological conditions such as stroke and dementia.

However, Dr Feifel emphasized that TMS is still in its "infancy." He said: "We are still a little bit groping in the dark. We know we've got a treatment. I don't think anyone doubts that this is efficacious and the data are quite convincing, but in terms of exactly how to use it, who responds best, what are the optimal parameters, exactly what can we expect in terms of long-term outcomes.... So many things we don't know.

"This modality can be improved so much because we're basically practising on a set of parameters that were almost established by arbitrary decisions that have become convention, so I'm really looking forward to seeing TMS get better and better as we figure out all the different aspects of it. TMS is still in it's newborn stage, it's still in it's infancy, but it's clear that this baby is a prodigy with tremendous potential," said Dr Feifel.

The registry is funded by NeuroStar TMS Therapy, part of Neuronetics.

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