NeuroStar TMS Therapy clinical data

ABOUT NEUROSTAR TMS THERAPY-CLINICAL DATA

How were the clinical trials designed and what were the results of the trials?

  • NeuroStar TMS Therapy was studied in depressed patients who had failed to receive benefit from prior antidepressant medications.
  • A six-week, randomized, placebo-controlled, double-blind, study was conducted to evaluate the safe and effective use of NeuroStar TMS as a monotherapy.
  • An analysis for predictors of response demonstrated that the patients with the best response to NeuroStar TMS Therapy were adults who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode.
  • They had received a median of four total prior antidepressant treatment attempts in the current episode, one of which achieved treatment adequacy at or above the minimal effective dose and duration.
  • In these patients, the following efficacy results were observed in the randomized, controlled study:
    • The primary efficacy measure was statistically significantly superior to placebo (p=0.0006) among NeuroStar-treated patients.
    • NeuroStar TMS Therapy-treated patients had statistically significant response and remission rates, which were approximately twice the rate of placebo-treated patients.
  • Patients who did not respond in the randomized, controlled study entered into a six-week, open-label treatment study. In the open-label study, which is most like real-world clinical practice, the following was observed:
    • Patients treated for the first time with NeuroStar TMS Therapy achieved a 54% response rate and a 33% remission rate on the HAMD 24-item scale at the end of six weeks.
    • Similar results were observed using the MADRS rating scale.
  • Throughout the NeuroStar TMS Therapy studies, more than 10,000 active TMS treatments were safely performed. The following were the safety results observed:
    • There were no systemic side effects, such as weight gain, sexual dysfunction, sedation, nausea, or dry mouth.
    • The most commonly reported side effect related to treatment was scalp pain or discomfort during the treatment session.
    • There was a less than 5% discontinuation rate due to adverse events.

Are the rates of response and remission clinically meaningful to patients?

  • Yes, particularly in patients who had failed multiple treatment attempts, one of which achieved an adequate dose and duration
  • In the RCT, almost 3 times the number of NeuroStar-treated patients had a significant improvement in symptoms compared to placebo.
  • That magnitude of difference is larger than that of most antidepressant medications approved for the treatment of depression, despite the fact that almost all medications have been studied and approved for first-line treatment.
  • In the open-label trial, which is most like the real world—one in two patients had a significant improvement and one in three had complete symptom resolution.
  • In addition to efficacy, NeuroStar’s safety/tolerability profile is also clinically meaningful.
  • It’s non-systemic, so it doesn’t cause side effects such as weight gain, sexual dysfunction, nausea, dry mouth, sedation, etc.
  • The most commonly reported side effect related to treatment was scalp pain or discomfort during the treatment session.

What were the patient selection criteria for the study?

  • Adults
  • Unipolar, non-psychotic
  • Had failed at least one, but no more than four, previous medications at an adequate dose and duration.

Do you have data on suicide and violent behaviors in the clinical trials?

  • There were no incidents of reported suicide or suicide attempts in patients treated with NeuroStar TMS Therapy during the clinical trials.
  • Patients who were at high risk of suicide were not included in our trial.

Does NeuroStar TMS Therapy work in other disorders? There are lots of studies in the literature suggesting it works in other areas.

  • NeuroStar has only systematically been evaluated in patients with unipolar, non-psychotic major depression.
  • While there is promising data in a variety of other disorders, these data are preliminary and require systematic evaluation in controlled clinical trials.
  • If you’d like more information on other potential uses for TMS, you can contact our Medical Affairs staff who can provide you with further information.

QUESTIONS ABOUT CYBERONICS VNS THERAPY, ECT AND OTHER TMS COMPANIES

How does it compare to Cyberonics’ VNS Therapy?

  • VNS Therapy is approved as an adjunctive treatment to treat depressed patients who have failed at least four previous antidepressant medications.
  • NeuroStar TMS can be used as a monotherapy and is intended to be used earlier in the treatment algorithm.
  • VNS is not approved as an acute treatment; NeuroStar is.
  • Unlike VNS, TMS Therapy is non-invasive and does not require surgery, anesthesia or sedation. With NeuroStar TMS, patients can return to their normal activities immediately after the 40-minute therapy session.
  • VNS Therapy requires a surgical procedure, during which the patient is anesthetized and has a device implanted in their neck and chest; NeuroStar is completely non-invasive.

How does it compare to ECT? Is this a replacement?

  • ECT (electroconvulsive therapy) and TMS both used applied energy to the brain to cause neural stimulation for relieving the symptoms of depression. ECT uses electrical energy applied to the whole brain, while TMS uses magnetic energy applied only to the left prefrontal cortex.
  • ECT is an effective acute treatment for major depression, but is highly invasive (causing seizure induction and requiring anesthesia) and has significant adverse effects. In contrast, TMS is also effective in patients with Major Depressive Disorder but is non-invasive and has an excellent safety profile.
  • TMS will likely be used much earlier in the treatment algorithm, because of its favorable risk/benefit ratio.
  • ECT will always have an important role for certain depression patients despite safety concerns; however, will be reserved as a “last resort.”

Isn’t NeuroStar TMS less effective than ECT?

  • NeuroStar TMS Therapy is an outpatient procedure.
  • Unlike ECT, TMS does not require anesthesia, sedation and the production of a convulsion.
  • Also different from ECT, NeuroStar TMS Therapy does not result in adverse effects on memory or concentration.
  • Because of these issues, ECT is often reserved as a last resort.
  • TMS will likely be used much earlier in the treatment algorithm, because of its favorable risk/benefit ratio.

March, 2009, NeuroStar TMS Therapy®