Now offering Accelerated TMS – Five-day TMS therapy

Summary:
Since 2011 TMS Huntsville has been treating patients with a standard daily treatment protocol of 36 treatments (or more) stretched out over 9 weeks.  Recently the FDA has cleared a protocol of 50 treatments delivered in 5 days.  A modified application of this treatment is now offered at TMS HSV. Response data from patients treated so far is available on request.

Explanation of FDA cleared SAINT Protocol
SAINT Protocol – Stanford Accelerated Intelligent Neuromodulation Therapy
Since 2008 with the FDA approval of TMS therapy, patients undergo treatment over a six-week period and then usually taper the following three weeks. Over the last 10 years, studies utilizing TMS therapy delivered multiple times a day have shown benefits in accelerating patient response. Now the FDA has cleared an accelerated protocol that delivers 50 treatments during five days.

This protocol was developed at Stanford University and data was published in the American Journal of Psychiatry in 2021 Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial . In this study, nearly 80% of treated patients achieved remission from depression compared to 13% that received sham (placebo) treatment .  Sham treatment is the delivery of a pulse sensation to the treatment site that does not have a real treatment effect. The sensation mimics the “real treatment” sensation.

What was the schedule and equipment in the SAINT study?
The treatment protocol had patients receiving a 9-minute treatment once per hour 10 times a day with a 50 min rest between sessions for five days. The TMS system utilized a MagVenture Stimulator. Pulses were delivered using intermittent Theta Burst (iTBS) . MagVenture was granted FDA clearance for this second generation TMS type in 2018.

Is Accelerated TMS safe?
Very few side effects occurred during the study. Some patients noted slight fatigue and the frequency of headache was slightly higher compared with the sham placebo TMS group.

Pros of Accelerated Treatment
Certainly, treatment that is completed in five days offers an advantage over the traditional six week plus tapering phase of traditional TMS therapy. The high remission rate with multiple treatments per day also suggests this treatment may be more effective than once daily TMS.

Cons of Accelerated Treatment
This treatment is not yet covered by insurance companies and represents a higher out of pocket cost. The durability of the treatment has not been as well-established as traditional once daily treatment. It could be that patients may need TMS treatment reintroduction more frequently in the future to maintain response.

TMS Huntsville protocol for Accelerated TMS
At TMS Huntsville, we are utilizing a MagVenture TMS System stimulator providing intermittent Theta Burst Stimulation similar to the original study. Treatments are 9 min as in the original study with a 50 min rest between treatments. One difference would be the placement of the coil on the scalp. We utilize anatomical landmarks on the skull to approximate the coil position. This approach has been utilized for the last several years  great success over a wide variety of patient types.

In the Stanford study, patients underwent structural and functional MRI studies before treatment. During treatment, neuronavigated coil  positioning allowed the researchers to choose a position that could enhance treatment response.

Magnus Medical was given the FDA clearance for the SAINT protocol but currently Magnus neuronavigation mapping systems are not available for individual psychiatry practices. These systems may become available in limited supply in 2023. 

More research is needed to determine which aspects of the SAINT protocol have the most impact on response, but it is reassuring that protocols utilizing more than one treatment per day have shown advantages in multiple studies over the last several years.

DISCLAIMER: SAINTTM is a trademark of The Board of Trustees of the Leland Stanford Junior University (“Stanford”) and Magnus Medical is licensed to use this term. TMS Huntsville is not endorsed nor licensed by Magnus Medical or Stanford, and does not claim to be offering the SAINT protocol as prescribed by Stanford University et. al. or Magnus Medical.