NeuroStar® Clinical Results
NeuroStar TMS Therapy for depression has the largest clinical data set of any TMS treatment. Clinical studies with 800 patients have shown that NeuroStar TMS Therapy can help achieve remission for patients living with depression.
For many patients, depression symptoms significantly improved or went away after 4 to 6 weeks of treatment with NeuroStar TMS Therapy. In the clinical trials
- 1 in 2 patients experienced significant improvement (50% response rate)
- 1 in 3 patients were symptom free (33% remission rate)
Impressive data in clinical trials is required for Food and Drug Administration approval, and this impressed the hard to please FDA.
Our NeuroStar TMS Therapy System is FDA approved. We wouldn’t have it any other way, but FDA approval is just the beginning.
What happens in the real world? Clinical trials are one thing, but our patients are real people, not research subjects. How does TMS work in the doctor’s office.
This is where it gets interesting! TMS works better than the clinical trials show…
The real world results – in doctors’ offices with real patients – of TMS treatment for depression are better than the results in formal clinical trials. In Georgia, using NeuroStar TMS, recently analyzed data shows
- 9 of 10 patients experienced significant improvement (90% response rate, defined as 50% reduction in symptoms)
- 3 of 4 patients were symptom free (75% remission rate)
These are very, very impressive results especially when they are compared to the results using medications. Besides, TMS produces no systemic side effects, whereas drugs, which can be far less effective than TMS, oftentimes lead to frequent, bothersome side effects,
Sham studies are impressive, too. In a pivotal trial, patients who were treated with NeuroStar TMS Therapy had more than 3 times greater symptom improvement at 4 weeks than patients who had placebo treatment (MADRS, -7.1 vs -2.1, P=0.0006).
TMS was included in the 2010 American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients with Major Depression—guidelines that provide recommendations for how psychiatrists treat depression.
Depression Must Be Treated To Remission No Matter What It Takes!
We know depression is painful. We know remission is the only acceptable goal. We’re interested in our patients achieving remission, and aren’t satisfied until remission is achieved.
Anything that removes the stumbling blocks of depression is useful, particularly if it doesn’t cause more problems. We’re interested in helping our patients, and minimizing side effects.
Alone, transcranial magnet stimulation therapy often works well, as the clinical trials show. The clinical trials studied patients who were not on any medications for depression. But, patients in clinical trials aren’t much like patients in real life, because real life patients are usually already on medications.
Having participated in clinical trail research, we know how frustrating it is to try to find depressed people who aren’t already on medications.
We are much more interested in the real world data for several reasons.
- In the doctor’s office or psychiatric clinic most treatments (like antidepressants) achieve results which aren’t as good as the results in clinical trial research.
- In doctors’ offices most people with depression are already on antidepressant medications before TMS is considered.
- In the real world TMS works better than in the clinical trials, perhaps because in doctors’ offices TMS is usually used on top of ineffective medications.
- In the doctor’s office, TMS is very effective in helping real people. Even if we’re not sure exactly why it helps, we know it works great.
- We’re not trying to impress the FDA. Instead we want to help our patients in their real lives.
No one is entirely sure why TMS works better in the real world than in clinical trials, but it may have something to do with the combination of antidepressants and TMS. In other words, TMS may be the secret sauce to get medications (which without TMS are not effective) to suddenly become effective.
In October we are going to the Medical University of South Carolina to study for a full week with one of the big wig researchers in the world of brain stimulation, Dr. Mark George. We’ll have the opportunity to ask him questions such as why is the real world data so much better than the clinical trial data?
There will always be unanswered questions, and ongoing research leading to more questions. In the meantime, it’s important to understand the good news.
Real world data shows that in Georgia TMS combines well with antidepressant medications to produce better results than what was demonstrated in the clinical trials to satisfy the FDA. Since most people who receive TMS therapy are already on antidepressants, this is wonderful news.
Treating depression to remission is our standard. We want to stamp out depression worldwide, beginning in our own backyard of Augusta, Georgia, and having TMS available for our patients is a real plus.
Carpenter LL, et al. (2012). Depress Anxiety, 29(7):587-596.
Demitrack MA, Thase ME. (2009). Psychopharmacol Bull, 42(2):5-38.
O’Reardon JP, et al. (2007). Biol Psychiatry, 62(11):1208-1216.
George MS, et al. (2010). Arch Gen Psychiatry, 67(5):507-516.
Janicak PG, et al. (2010). Brain Stimulation, 3(4):187-199.
American Psychiatric Association (2010) (eds: Gelenberg AJ, Freeman MP, Markowitz JC, Rosenbaum JF, Thase ME, Trivedi MH, Van Rhoads RS). Practice Guidelines for the Treatment of Patients with Major Depressive Disorder, 3rd Edition.
Also See: Ongoing Clinical Trials