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NeuroStar TMS Therapy® is indicated for the treatment of Major Depressive
Disorder in adult patients 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.
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What is TMS Therapy?
TMS stands for transcranial magnetic stimulation. It is used to treat depression
by stimulating the brain non-invasively using an electromagnetic field, similar to
those magnetic fields produced by an MRI machine. During TMS Therapy, a magnetic field is administered
in very short pulses to the part of your brain that research has demonstrated to
be associated with depression. The typical initial course of treatment is about
37 minutes daily over 4-6 weeks.
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How does TMS Therapy work?
The NeuroStar TMS Therapy system uses short pulses of magnetic fields to stimulate
the area of the brain that is thought to function differently in patients with depression.
The magnetic field produces an electric current in the brain that stimulates the
brain cells (neurons). This results in changes in the brain that are thought to be beneficial
in the treatment of depression.
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Is TMS Therapy a good alternative for patients who cannot tolerate
the side effects associated with antidepressant medications?
NeuroStar® is non-systemic (does not circulate in the blood throughout
the body), so it does not have side effects such as weight gain, sexual dysfunction,
nausea, dry mouth, sedation, among others that are commonly found with antidepressant drugs.
The most common side effects reported with NeuroStar TMS during clinical
trials were headache and scalp pain or discomfort – generally mild to moderate –
occurring less frequently after the first week of treatment.
NeuroStar TMS Therapy is cleared by the U.S. Food and Drug Administration
(FDA) for the treatment of patients with depression who have failed to achieve satisfactory
improvement from prior antidepressant medication.* TMS Therapy may not work for all patients with depression.
You should speak with your doctor to determine if TMS Therapy is an appropriate treatment option
for you.
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Is TMS Therapy like other alternative therapies which use magnets
to treat some illnesses?
No. TMS Therapy involves a unique method of using pulsed magnetic fields for
therapeutic benefit. The intensity of the magnetic field is similar to that of the
magnetic fields used in magnetic resonance imaging, or MRI. These techniques differ
radically from the use of low intensity, static magnetic fields. These products
deliver weak and undirected static fields that are not capable of activating brain
cells.
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Is TMS Therapy like electroconvulsive therapy (ECT)?
No, the two procedures are very different. While both are effective in the treatment
of depression, there are many differences in safety and tolerability.
During the TMS Therapy procedure, patients sit in a chair and are awake and alert
throughout the entire 37-minute procedure – no sedation is used with TMS Therapy.
Patients can transport themselves to and from treatment.
In over 10,000 active treatments with NeuroStar TMS Therapy in clinical trials,
no seizures were observed. TMS Therapy was also shown to have no negative effects
on memory function in clinical studies. However, there is a remote risk of seizure with TMS Therapy.
In contrast, "shock therapy," or electroconvulsive therapy (ECT), intentionally
causes a seizure. Patients receiving ECT must be sedated with general anesthesia
and paralyzed with muscle relaxants. Recovery from an ECT treatment session occurs
slowly, and patients are usually closely monitored for minutes or a few hours after
a treatment.
Short-term confusion and memory loss are common with ECT, and long-term disruptions in memory
have been shown to occur and may persist indefinitely in some people. Because of
the side effects associated with ECT, a significant amount of caregiver support
is required.
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What is a typical course of treatment with NeuroStar TMS Therapy?
In clinical trials, patients received NeuroStar TMS Therapy 5 times per week for
37 minutes sessions over 4-6 weeks.
Patients treated with NeuroStar TMS Therapy should receive treatment for a minimum
of four weeks with additional treatments based on clinical judgment.
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What are the potential risks of NeuroStar TMS Therapy?
NeuroStar TMS Therapy is well tolerated and has been proven to be safe in clinical
trials. Throughout over 10,000 active treatments performed in clinical trials, the
most commonly reported side effect related to treatment were scalp pain or discomfort during
treatment sessions. These side effects were generally mild to moderate, and occurred
less frequently after the first week of treatment. Less than 5% of patients treated
with NeuroStar TMS Therapy discontinued treatment due to side effects.
In NeuroStar clinical trials, over 10,000 TMS treatments demonstrated its safety,
with no occurrence of seizures. However, there is a small risk of a seizure occurring
during treatment. This risk is no greater than what has been observed with oral
antidepressant medications.
While NeuroStar TMS Therapy has been proven effective, not all patients will benefit
from it. Patients should be carefully monitored for worsening symptoms, signs or
symptoms of suicidal behavior, and/or unusual behavior. Families and caregivers
should also be aware of the need to observe patients and notify their treatment
provider if symptoms worsen.
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Does NeuroStar TMS Therapy cause brain tumors?
No, NeuroStar TMS Therapy uses the same type and strength of magnetic fields as
MRIs (magnetic resonance imaging), which have been used in tens of millions of patients
around the world and have not been shown to cause tumors. The magnetic energy used
in a full course of TMS Therapy is a small fraction of just one brain scan with
an MRI.
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Does NeuroStar cause memory loss?
No, NeuroStar TMS Therapy was systematically evaluated for its effects on memory.
Clinical trials demonstrated that NeuroStar TMS Therapy does not result in any negative
effects on memory or concentration.
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Is TMS Therapy uncomfortable?
The most common side effects related to treatment was scalp pain or discomfort during treatment
sessions. These side effect were generally mild to moderate, and occurred less frequently
after the first week of treatment.
If necessary, you can treat this discomfort with an over-the-counter analgesic.
If these side effects persist, your doctor can temporarily reduce the strength of
the magnetic field pulses being administered in order to make treatment more comfortable.
Less than 5% of patients treated with NeuroStar TMS Therapy discontinued treatment
due to side effects.
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How long does the antidepressant effect last? Will I need any therapy
beyond the first 4-6 weeks?
In most patients, the clinical benefit of NeuroStar TMS Therapy was maintained through
6 months of follow-up study. Talk to your doctor about your long-term treatment
path.
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Can I also take antidepressant(s) if I am receiving NeuroStar TMS
Therapy?
Yes. In clinical trials, NeuroStar TMS Therapy was safely administered with and
without other antidepressant medications.
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Does FDA-clearance of the NeuroStar TMS Therapy system mean that
all TMS devices can be used to treat major depression within the United States?
No, the NeuroStar TMS Therapy system is the first and only TMS device to be cleared
by the U.S. Food and Drug Administration (FDA) for the treatment of major depression.
The NeuroStar TMS Therapy system is also the first and only TMS device to have been
evaluated in a large, multicenter, controlled clinical trial for the treatment of depression.
No other TMS device can claim to be "FDA-cleared" for the treatment of depression.
These devices have not been proven to be safe and effective for treating depression.
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Will NeuroStar TMS Therapy be covered by my insurance and/or Medicare?
NeuroStar TMS Therapy may be covered on a case-by-case basis. You can work with
your doctor and the NeuroStar Care Connection (NCC) program to seek case-by-case
coverage. The NCC staff is made up of trained case managers that can help you and
your doctor with the reimbursement process. Learn more about the
NeuroStar Care Connection.
In the mean time, out-of-pocket payment may be required. NeuroStar TMS Therapy can
be paid from healthcare flexible spending account. Clark Behavioral Health Financing
will also help you develop a financing plan as needed. Learn more about how
Clark
Behavioral Health Financing
can help.
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