Accelerated TMS Therapy Tampa

Theta Burst Stimulation Tampa FL

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Accelerated Transcranial Magnetic Stimulation

TMS Therapy for Depression in 5 Days ✔

Florida TMS Clinic provides the newest innovation to our patients. Florida TMS Clinic provides navigated rTMS, navigated iTBS, accelerated TMS and TBS. Florida TMS Clinic doesn’t use fcMRI-guided targeting as of the time of this publication as it is not FDA-cleared yet nor available for non-research centers. That being said, we are committed to providing our patients with the most up-to-date proven treatment options in the Tampa Bay Area.

What is Accelerated TMS?

The term accelerated TMS is used in the medical literature to describe any TMS therapy protocol applying more than one TMS session a day. Today, the terminology accelerated TMS and accelerated TBS is commonly used to describe the TMS therapy protocol in which the patient gets 10 TMS therapy sessions a day for 5 days for a total of 50 TMS therapy sessions. This accelerated TMS therapy protocol shortens the duration of treatment from 6 weeks to just 5 days. Accelerated TMS therapy is particularly interesting because it could improve the way we do TMS therapy for depression drastically.

Traditional treatments for depression like antidepressant medications and talk therapy are facing many challenges. It’s not uncommon for such treatments to be ineffective. It takes, what feels like, forever to get some response. And of course, medications are associated with frequent side effects. Thanks to repetitive Transcranial Magnetic Stimulation (rTMS) and intermittent Theta Burst Stimulation (iTBS), now we have an alternative effective treatment for treatment-resistant depression (TRD).

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TMS therapy has been used in clinical psychiatric practice since 2008 in the USA following its clearance by the FDA. It is non-invasive, drug-free with none of the systemic side effects associated with medications. Despite the breakthrough it provided, rTMS is challenged by the inconvenience of the duration of the treatments. A TMS therapy session takes between 19 to 37 minutes. When you consider that a full treatment course is about 30 sessions, that’s a lot of time on the treatment chair.

Fast forward 10 years to 2018, a new breakthrough in TMS revolutionized our treatment options. Intermittent Theta-Burst Stimulation (iTBS) is the “version 2.0” of rTMS. Just like rTMS, iTBS is a non-invasive brain stimulation treatment that is FDA-cleared for treatment-resistant depression (TRD). It uses a different magnetic pulse at a higher frequency, delivering the treatment in just about 3 minutes. iTBS was proven in 2018 to be as effective as rTMS with the obvious time saving of over 5 folds. This also opened the door wide open to newer methodologies of providing the treatment. Most importantly, providing multiple sessions a day. This is called accelerated TMS. Accelerated TMS evolved over time to allow the course of the treatment to be shortened from 6 weeks to just 5 days!

Is Accelerated TMS Therapy Effective?

Clinical research supports the efficacy of accelerated TMS therapy for depression treatment. Let’s look at the evidence available today!

A significant amount of research done exploring accelerated TMS started in Europe, particularly in Belgium. Based on a 2014 study it was concluded that Accelerated TBS treatment in depressed suicidal patients is safe and well-tolerated and may have the potential to acutely decrease suicidal ideations.

A couple of years later a study was published in the Journal of Affective Disorders in 2016 found that 20 sessions of iTBS Given 5 sessions a day for only four days of accelerated iTBS treatment applied to the left DLPFC in TRD may lead to meaningful clinical responses within two weeks after stimulation.

Then in a clinical trial published in 2018, the group compared accelerated high-frequency rTMS (arTMS) with accelerated intermittent theta burst stimulation (aiTBS) in the refractory depressed state. The clinical efficacy was not significantly different between both protocols. This substantiates the potential of the accelerated stimulation to shorten the treatment duration from the depressed state to the response state. Any time gain from the depressed state to the recovered state is in the patients’ interest.

What is SAINT Protocol?

The recent breakthrough in accelerated TMS came from Stanford University and was published in the prestigious peer-reviewed American Journal of Psychiatry in April 2020. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression (SAINT-TRD) proved the efficacy and safety of accelerated TBS protocol for depression. In this clinical trial, 21 participants with TRD received 50 iTBS sessions as 10 daily sessions over 5 consecutive days. Amazingly, 19 of 21 participants (90.48%) met the criteria for remission immediately after SAINT. In the intent-to-treat analysis, 19 of 22 participants (86.4%) met remission criteria. Neuropsychological testing demonstrated no negative cognitive side effects. This supported that accelerated iTBS was well tolerated and safe. Efficacy was surprisingly high.

A randomized controlled trial was conducted to validate this effect. The official results are not published yet. But the group presented their findings in an oral presentation that confirms the same conclusion. Which is the high efficacy of accelerated TMS or accelerated TBS as a form of TMS treatment. This page will be updated with numbers once the results are published in a peer-reviewed publication.

The Clinical TMS Society put out a statement in November of 2020 cautioning the widespread use of accelerated TMS in the community. I am quoting the exact statement below for full disclosure of all the opinions in the field.

Clinical TMS Society SAINT protocol statement

Start of the quotation from the Clinical TMS Society SAINT protocol statement:

“There has been widespread interest in a recent study published by Cole et al. using a novel accelerated, high-dose intermittent theta burst stimulation protocol for treatment-resistant depression, which they named the Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT. Neuro-imaging was used for targeting and placement of the coil on the patients’ heads was performed prospectively and at the single-subject level.

Shorter stimulation protocols such as iTBS are now available to improve clinical efficiency. While exciting, the results should be considered preliminary as the authors point out resulting effect sizes cannot be considered reliable given the small sample size and the uncontrolled study design. The administration of all-day stimulation sessions certainly increases the possibility of a placebo effect. The field of brain stimulation, much like the rest of psychiatry, has often failed to replicate positive results under double-blind conditions. Thus, enthusiasm for these results must be tempered until we have results from a sufficiently powered randomized controlled trial. A larger study, with randomization to sham or active SAINT, is necessary to determine efficacy before it could be called an evidence-based, standard-of-care approach to treatment of depression. Additionally, neuroimaging expertise, with specific MRI protocols and data pre-processing and analysis pipelines, are resources required to perform individualized connectivity analysis and deliver MRI-navigated stimulation in SAINT, the way these researchers did. This is not easily available to the wider TMS community at this time. At the end of the SAINT week, 86% were in remission (MADRS score < or equal to 10). One month following SAINT, 57% of the participants were in remission and 67% were responders. Therefore, additional data is required to assess durability of this TMS treatment protocol.

At this time the SAINT protocol should be considered experimental and is not recommended for widespread community use.

Approved by the CTMSS Board on 11.04.2020”

End of quotation from the Clinical TMS Society SAINT protocol statement.

References

References:

Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26. Erratum in: Lancet. 2018 Jun 23;391(10139):e24. PMID: 29726344.

Desmyter S, Duprat R, Baeken C, Bijttebier S, van Heeringen K. The acute effects of accelerated repetitive Transcranial Magnetic Stimulation on suicide risk in unipolar depression: preliminary results. Psychiatr Danub. 2014 Nov;26 Suppl 1:48-52. PMID: 25413512.

Duprat R, Desmyter S, Rudi de R, van Heeringen K, Van den Abbeele D, Tandt H, Bakic J, Pourtois G, Dedoncker J, Vervaet M, Van Autreve S, Lemmens GM, Baeken C. Accelerated intermittent theta burst stimulation treatment in medication-resistant major depression: A fast road to remission? J Affect Disord. 2016 Aug;200:6-14. doi: 10.1016/j.jad.2016.04.015. Epub 2016 Apr 19. PMID: 27107779.

Baeken C. Accelerated rTMS: A Potential Treatment to Alleviate Refractory Depression. Front Psychol. 2018 Oct 31;9:2017. doi: 10.3389/fpsyg.2018.02017. PMID: 30429807; PMCID: PMC6220029.

Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7. PMID: 32252538.

https://www.clinicaltmssociety.org/sites/default/files/ctmss_saint_protocol_statement_11.04.2020_0.pdf

Accelerated TMS at Florida TMS Clinic

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Florida TMS Clinic provides the newest innovation to our patients. Florida TMS Clinic provides navigated rTMS, navigated iTBS, accelerated TMS and TBS. Florida TMS Clinic doesn’t use fcMRI-guided targeting as of the time of this publication as it is not FDA-cleared yet nor available for non-research centers. That being said, we are committed to providing our patients with the most up-to-date proven treatment options in the Tampa Bay Area.

In 2019, we were following the European accelerated TBS protocol mentioned above. We treated 13 patients with 30 treatment sessions over 5 or 6 days. We had positive results. We are working on extracting the data to publish our findings in the future.

In 2020, and as we were more convinced with Stanford’s data, we pivoted our treatment protocol to 50 treatments over 5 days, matching SAINT protocol minus the fcMRI targeting. Our results were in unity with SAINT-TRD.

We presented our work at the CTMSS 2021 meeting in a poster presentation. Below is the abstract:

Title, Authors & Affiliations

Title: Non-MRI-Guided Accelerated Intermittent Theta Burst Stimulation Is Effective In Depression.

Authors: Mhd Khaled Bowarshi1, Joanna Isaac2, Michaela McMahon3, Aliaa Al-Sabbagh4

Affiliations:

1Florida TMS Clinic, Florida/USA
2Florida TMS Clinic, Florida/USA
3Florida TMS Clinic, Florida/USA
4Florida TMS Clinic, Florida/USA

Only one patient didn’t show a significant clinical response. Also, though patient #3 had a substantial response on MADRS, the subject was excluded from our total count because PHQ-9 was not consistent with severe depression.

Our data support the efficacy of accelerated TMS without fcMRI targeting. This is more consistent with the clinical practice today, which typically doesn’t involve fcMRI targeting. Holding back on accelerated TMS awaiting the breakthrough of individualized targeting to become mainstream may not serve the best interest of our patients’ population suffering from depression and looking for a faster and more efficient treatment option.

Background

Conventional daily TMS therapy five days a week for six weeks might not be practical for all patients suffering from depression. Time constraints and distance from the clinic are the main two obstacles. Emerging data showed that accelerated TMS and accelerated TBS could be as effective. A higher response rate was reported using fcMRI-guided accelerated iTBS in SAINT-TRD, which can be [partitally] attributed to individualized neuro-connectivity targeting. In this study, we report retrospective data analysis of non-MRI-guided accelerated intermittent theta burst stimulation.

Methods

Six patients with depression, five unipolar and one bipolar II, all had severe treatment-resistant depression (> 4 antidepressant history), two with a previous history of receiving TMS therapy, received accelerated iTBS. Stimulation with F-8 coil was administered to the left dorsolateral prefrontal cortex (DL-PFC) determined using StimGuide, a non-MRI based navigation system. Stimulation was at 90% MT intermittent theta burst (iTBS) for 1800 pulses with an intertreatment interval of fifty minutes. Patients received ten sessions every day for five consecutive days for a total of fifty sessions. PHQ-9 (two patients), HAMD-6 (three patients), or MADRS (one patient) were collected at the start and the end of the treatment course.

Results

Five out of the six patients responded to accelerated iTBS. The response was identified as a 50% reduction of depressive symptoms on the depression scale they were initially assessed with.

Conclusion

Results indicate that non-MRI-guided accelerated intermittent theta-burst stimulation reduced depression symptoms in depressed patients with treatment resistance.