Hope-TMS-of-NY-TMS Efficacy-Durability/Safety data
       Hope TMS and Neuropsychiatric Center 
646 558 5299
Elvin Ruiz M.D.
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57 West 57th Street       Suite 808       New York, New York       10019
57 West 57th Street      Suite 808      New York, New York      10019
Efficacy/Durability Summary
NeuroStar TMS Therapy has been evaluated for its efficacy, safety, tolerability and durability of effect in a series of recently completed clinical studies. In the acute treatment trial, patients with pharmacotherapy resistant major depression were treated with up to 30 treatments (typically provided over 6 weeks), plus a 6 treatment taper over an additional 3 weeks. In this prospectively randomized, sham (placebo)-controlled, triple-blind trial, no antidepressant medications were allowed (TMS Therapy as a monotherapy) until the taper phase. The study population consisted of patients who had failed a number of previous antidepressant medication attempts during their current depressive episode. 97% of patients had recurrent illness and 50% were unemployed due to their illness. NeuroStar TMS Therapy resulted in statistically significant improvement in response and remission rates compared to sham treatment. See Figure 2. Based on the MADRS depression symptom rating scale, 28% of patients responded at of 36 treatments, more than twice that of the sham response. Remission rates were also more than twice that of sham with 21% patients getting totally well by the end of the taper phase. The majority of responders also achieved remission.
Responders: Patients who responded in the acute study discussed above were subsequently enrolled in a 6-month extension study where they then received single medication treatment, and were observed for durability of response. The 6-month study demonstrated that approximately 50% of the patients previously treated with NeuroStar TMS Therapy maintained their response with a single medication treatment without the need for additional treatment with NeuroStar TMS Therapy.

Non-responders: Patients who did not respond in the acute study (this included patients from both the sham and active treatment arms) entered into a 6-week, open-label treatment study followed by a 3 week taper phase. In the open-label study, 45% of previously sham arm patients had a >50% improvement in symptoms and 31% had complete remission of their symptoms (MADRS <10). See Figure 3. In those patients that did receive TMS Therapy initially but did not meet criteria for response, an additional 34% received a >50% improvement in symptoms and 18% showing remission of symptoms

The importance of this open-label data is twofold.

First, the results represent most closely what can be expected in the real world clinical setting. Clinicians can expect about 1 in 2 patients to have a significant clinical improvement with the majority reaching remission.

 Secondly, it is evident that additional TMS therapy past 6 weeks may provide additional benefit for the more difficult to treat patients,
  • Over the complete series of trials, >10,000 active treatments were safely preformed.
  • No seizures were reported during these trials.
  • No systemic side effects like those typical with oral antidepressants such as sedation, cognitive-blunting, weight gain, sexual dysfunction, dry mouth, constipation or nausea were reported.
  • The most commonly reported side effects were headache and scalp discomfort directly under the electromagnet. These side effects were generally mild to moderate and dissipated markedly after the first week of treatment.
  • No cognitive impairments such as memory loss or other negative effects on cognition were observed. This is in stark contrast to what is often seen with ECT.
  • Less than 5% of patients in the active arm of the study discontinued due to side effects, which did not differ significantly from sham arm patients. This can be contrasted to what is typical in pharmacotherapy trials where discontinuation rates due to side effects are 15-25%.
  • TMS Therapy is contraindicated for patients with ferromagnetic material in their heads, including implanted aneurysm coils or metal plates/screws in their skull.