In a clinical trial, the expedited Transcranial Magnetic Stimulation device produced a patient response/remission rates of 32% depressive symptom improvement rates of 49%.
The US Food and Drug Administration (FDA) has approved a new magnetic stimulation device that is designed to treat patients with treatment-resistant major depressive disorder (MDD) in just 3 minutes.
The Express Transcranial Magnetic Stimulation (TMS) device, from MagVenture, has been approved by the FDA—expediting the treatment session speed set only by the company’s preceding TMS device when it was first cleared in 2008. What was once a treatment regimen that required patients with MDD to undergo a 30-minute-plus session 20-30 times, is now capable of being completed in just 3 minutes per session.
Currently, the non-invasive, alternative therapy TMS device is the one of its kind on the US market. The MagVenture therapy delivers magnetic pulses to stimulate patient nerve cells, exciting neurons and altering their state of mood. It was approved on the backing of the largest double-blinded, randomized TMS trial to date.
Investigators analyzed the effects of the therapy in 414 patients with MDD. They randomly allocated 205 patients to receive high-frequency (Hz) TMS and 209 to receive intermittent theta burst stimulation (iTBS), administered to the left dorsolateral prefrontal cortex, 5 days per week for 4—6 weeks. Primary outcome was set at 17-item Hamilton Rating Scale for Depression (HRSD-17) score. The non-inferiority margin was set at 2.25 points.
In the TMS patient group, HRSD-17 scores improved from 23.5 (SD 4.4) to 13.4 (7.8). Similarly, the iTBS group reported mean score improvements of 23.6 (4.3) to 13.4 (7.9; P = .0011). Patient self-reported intensity of pain associated with the treatment, however, was notably greater in the iTBS group than the TMS group, reporting mean verbal analogue scale scores of 3.8 (SD 2.0) out of 10, versus 3.4 (2.0; P = .011), respectively.
Investigators also noted response/remission rates were 32% for those receiving the TMS therapy. Another 49% had an improvement in their depressive symptoms—rates which were similar to the standard, longer TMS protocol.
Kerry Rome, vice president of sales for MagVenture, noted that patients currently receiving standard TMS therapy can upgrade to the new Express option.
“This will enable our many customers to treat far more patients per day without having to invest in another TMS device,” Rome said in a statement. “For people needing treatment, this will also be a huge benefit, as treatment will now take up less of their time.”
According to MagVenture, most private health insurers cover the therapy, and the company’s devices have broadened in the US since 1000-plus psychiatric clinics have emerged since TMS entered the market 10 years ago.