By John O’Reardon, MD (Bio)
In September 2018, the FDA cleared a transcranial magnetic stimulation (TMS) device to be marketed for the adjunctive treatment of obsessive-compulsive disorder (OCD). This was a boost for sufferers of OCD and also for the field of brain stimulation (neuromodulation) because this is the first time a TMS device has been cleared by the FDA for the treatment of OCD.
For the FDA’s announcement and letter, and the FDA-approved Physician and Patient labeling, see the References below.
Why is this important?
The prevalence of OCD worldwide is estimated to be about 2% of the population. SSRIs, clomipramine, and exposure/response prevention psychotherapy treat about 50% of OCD cases effectively leaving a large proportion of patients who are treatment-resistant. Also, about 15% of OCD patients follow a deteriorating course. So, more treatment options are definitely needed.
Brainsway® and “Deep TMS (dTMS)”
Although as of 2018 there are now seven TMS devices that have been cleared by the FDA for the treatment of major depressive disorder, the clearance for the treatment of OCD approval is specific only to the “deep TMS” device manufactured by Brainsway.
What does “deep TMS” (dTMS) mean?
By using a different type of coil, the effects of the Brainsway device can reach a depth of about 5 cm below the surface of the brain. This is in contrast to about 2 cm below the surface that other TMS devices reach. This is why what the Brainsway device delivers is called “deep” TMS.
FDA clearance of a device versus approval of a medication
It is worth noting that the FDA requirements for the “clearance” of a medical device for marketing are quite different from those for “approval” of a drug. We will explain these differences on a separate page on this website.
According to the FDA’s announcement (see References below), the clearance of the Brainsway device for the treatment of OCD was done under the “de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.”
Clinical trial of deep TMS for OCD
This clinical trial comprised 100 subjects in an international multicenter randomized double blind trial comparing deep TMS to a placebo (sham) arm.[Editor: As of September 19, 2018, this trial has not been published in a peer-reviewed journal. Only some limited information about the trial is publicly available. See References below. So, Simple and Practical Mental Health is unable to adequately evaluate the trial at this time. An interim analysis of the study was published (Carmi et al., 2018)]
Patients could be included in the trial if their OCD had failed to respond to at least one SSRI and they were obtaining unsatisfactory improvement from a trial of exposure/response-prevention, which was maintained during the study.
A total of 30 sessions of TMS over six weeks of treatment with 2000 pulses per session was administered. The brain target selected for stimulation, based on neuroimaging findings, was the region of the anterior cingulate gyrus and medial prefrontal cortex. A unique aspect of the trial was the use of symptom provocation before each session. Here the patient had a script read or had a photograph shown to induce symptoms which meant that the circuit was now activated before stimulation, which was hypothesized to increase the benefits of TMS. The severity of the OCD was measured using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS).
After six weeks of treatment with deep TMS or sham treatment, 38% of patients who received deep TMS responded compared to 11% of those who got sham “TMS.” This 27% difference (NNT 3.7) is considered clinically robust.
There were no serious adverse events and only relatively minor ones such as scalp discomfort headache and muscle twitching.
1. FDA clearance of deep TMS for OCD does not automatically mean that insurance companies will agree to pay for it.
2. Also, the insurance coverage (if any) will be, at least for now, specific to the Brainsway device. Not all clinicians who provide TMS have the Brainsway TMS device. Clinicians and patients can find a location that provides deep TMS using the Brainsway device by clicking on the link below:
FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder
Carmi L, Alyagon U, Barnea-Ygael N, Zohar J, Dar R, Zangen A. Clinical and electrophysiological outcomes of deep TMS over the medial prefrontal and anterior cingulate cortices in OCD patients. Brain Stimul. 2018 Jan – Feb;11(1):158-165. PubMed PMID: 28927961.
Lusicic A, Schruers KR, Pallanti S, Castle DJ. Transcranial magnetic stimulation in the treatment of obsessive-compulsive disorder: current perspectives. Neuropsychiatr Dis Treat. 2018 Jun 29;14:1721-1736. Review. PubMed PMID: 29988759; PubMed Central PMCID: PMC6029675.
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