Frequently Asked Questions
about TMS Therapy®
What is NeuroStar TMS Therapy?
The NeuroStar TMS Therapy system is the first and only TMS Therapy® device cleared by the FDA for the treatment of depression.
TMS Therapy is a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation, which stimulates nerve cells in an area of the brain that is linked to depression, by delivering highly focused MRI-strength magnetic pulses.
Patients being treated by NeuroStar TMS Therapy do not require anesthesia or sedation and remain awake and alert.
It is a 40-minute outpatient procedure that is prescribed by a psychiatrist and performed in a psychiatrist's office.
The treatment is typically administered daily for 4-6 weeks.
What happens during TMS Therapy? What's the Mechanism of Action?
During NeuroStar TMS Therapy, pulsed magnetic fields are repetitively transmitted into the left prefrontal cortex, the part of the brain that is thought to regulate mood, in order to stimulate the firing of neurons (nerve cells).
This is believed to trigger a cascade of neurochemical events, including the release of neurotransmitters (such as serotonin, norepinephrine, and dopamine) and to help normalize neurotransmitter function.
What is the FDA-cleared indication and what does it mean?
NeuroStar TMS Therapy is indicated for adult patients with major depressive disorder who failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. The important points are:
- NeuroStar TMS Therapy is for patients with MDD only who failed to benefit from prior antidepressant medications
- It was only studied in ADULTS (22 years by FDA definition) and was not studied in children (i.e., less than 18 years) or for geriatric use (i.e., older than 70 years)
- "One prior antidepressant medication at minimal effective dose and duration" means a previous antidepressant medication that was given at its minimum labeled dose for at least 4 weeks
- Patients had only ONE exposure that reached this level of adequacy (patients had also had a median of 4 exposures that did not reach this level of adequacy)
- "In the current episode" means all of this applies only to the current depressive episode, however, if the patient had NO treatment in the current episode, then one can look back to the prior episode to see if there was one adequate treatment to which the patient did not benefit
- The Antidepressant Treatment Record supplied by Neuronetics and described in the User Manual can be used by the physician to identify the indicated population
What is the history of TMS Therapy?
First used in 1985, TMS has been used by researchers around the world to help understand the function of different parts of the brain. Several hundred manuscripts have been published regarding its use in stimulating select regions of the brain. Since the mid 1990s, TMS has been studied as an antidepressant therapy.
In 2006, the largest randomized, controlled study ever conducted with TMS Therapy was completed. This study was sponsored by Neuronetics and utilized the NeuroStar TMS Therapy system
Recently, the NeuroStar TMS Therapy system, was cleared by the U.S. Food and Drug Administration for the treatment of adult patients with major depressive disorder who have failed to receive satisfactory improvement from prior medication antidepressant treatment — 4 attempts of which 1 was adequate in the current episode.
Is TMS Therapy like the magnetic bracelets?
No. There are four main differences between the magnet used in NeuroStar TMS Therapy and the regular magnets used in alternative therapies:
- Regular magnets are typically weak in field strength, while the magnets used in NeuroStar TMS Therapy are much stronger and the same as those used in MRI machines
- Alternative therapy magnets create magnetic fields which do not move in space or time. The magnet used in NeuroStar TMS Therapy is pulsed, which causes the magnetic fields to move rapidly over time. This rapid magnetic field movement is what stimulates brain cells.
- No scientific evidence exists to support the therapeutic benefit of regular magnets in the treatment of depression, while rigorous clinical trials have proven the effectiveness of NeuroStar TMS Therapy.
- NeuroStar TMS Therapy is cleared by the FDA, while regular magnets are not.
How long does a patient undergo TMS therapy?
In clinical trials, patients received NeuroStar TMS Therapy 5 times per week for approximately 40 minutes during each session for 4-6 weeks.
Patients should be treated for a minimum of four weeks with additional treatments based on clinical judgment.
INSURANCE FREQUENTLY ASKED QUESTIONS
Will treatment be covered by insurance and/or Medicare?
We certainly hope and expect that it will
However, the process for unique, new procedures like this to be reimbursed usually takes 1-2 years
We believe there are compelling reasons for it to be reimbursed:
- Target patients have few proven and tolerable options
- Rigorously-designed clinical studies
- Benefit-risk ratio compares favorably to alternatives
- Compelling health economics for payers
What is the cost at your facility?
The usual cost is $325 per session - less than most other locations, and we do offer a sliding scale for patients in need of treatment.