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How long does a patient undergo 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?
The most commonly reported side effect related to treatment are scalp pain or discomfort
during treatment. In clinical trials, this side effect was 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.
Seizures have been reported with the use of TMS in the clinical tial literature. No seizures
were reported with the use of the NeuroStar TMS System in over 10,000 treatment sessions in
clinical trials. Since the introduction of the NeuroStar TMS System into clinical practice,
seizures have been rarely reported. The estimated risk of seizure under ordinary clinical use
is approximately 1 in 30,000 treatments (0.0003% of treatments) or 1 in 1000 patients (0.1% of patients).
Not all patients will benefit from NeuroStar TMS Therapy. 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.
NeuroStar TMS Therapy is contraindicated in patients with implanted metallic devices
or non-removable metallic objects in or around the head. NeuroStar TMS Therapy
should be used with caution in patients with implanted devices that are controlled by physiological
signals. This includes pacemakers and implantable cardioverter defibrillators (ICDs). It should be used in caution with patients using wearable cardioverter defibrillators.
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Does NeuroStar® TMS cause brain tumors?
No, TMS Therapy uses the same type and strength of magnetic fields as MRIs, which
have been used in tens of millions of patients around the world and have not been
shown to cause tumors. The amount of magnetic field exposure for a full course of
TMS Therapy is a small fraction of just one brain scan with an MRI.
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Does NeuroStar® TMS cause memory loss?
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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Do patients experience any pain during TMS Therapy®?
The most common side effect related to treatment was scalp pain or discomfort during
treatment sessions. This side effect was 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.
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Are there other patients for whom NeuroStar TMS Therapy
could pose a risk? 1
Depression is a serious disease and patients
being treated with NeuroStar TMS Therapy should be carefully monitored for signs
or symptoms of worsening depression.
NeuroStar TMS Therapy has not been studied in patients who have not received prior
antidepressant treatment. Efficacy has not been established in patients who have
failed to receive benefit from two or more prior antidepressant medications at minimal
effective dose and duration in the current episode.
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How long does the antidepressant effect last? Do patients
require any maintenance therapy? 1
During the six-month maintenance of effect study with NeuroStar TMS Therapy, patients
were maintained on antidepressant monotherapy and received periodic NeuroStar TMS
Therapy for symptom worsening.
During this study, approximately half of patients experienced some form of symptom
breakthrough and required TMS Therapy re-treatment. However, patients previously
treated with NeuroStar TMS Therapy had less than 10% relapse rate at the end of
6 months.
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Can patients receiving NeuroStar TMS Therapy also take antidepressant(s)?
Yes. In a randomized controlled trial, NeuroStar TMS Therapy was studied as a monotherapy
treatment without antidepressant medication so efficacy with additional antidepressants
(i.e., as adjunctive therapy) is not known. However, patients were safely administered
antidepressant medications during the taper phase of acute treatment.
NeuroStar TMS Therapy was also safety administered in conjunction with antidepressant
medication during the six-month maintenance of effect study. 1 Patients being treated
with antidepressant monotherapy who experienced depression symptom breakthrough
were given periodic reintroduction of TMS Therapy. There are also extensive literature
reports of safe use of TMS Therapy in conjunction with antidepressant medications.
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Does clearance of NeuroStar TMS Therapy®
System mean that all TMS devices are cleared for use in 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 large, multicenter, controlled clinical trials 2,3.
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 in treating depression.
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Will NeuroStar TMS Therapy be covered by insurance and/or
Medicare?
NeuroStar TMS Therapy may be covered on a case-by-case basis. Patients can work
with their provider and the
NeuroStar Care Connection (NCC) program
to seek case-by-case
coverage. NCC is staffed by trained case managers to help providers and patients
with the reimbursement process. In the mean time, out-of-pocket payment is required.
NeuroStar TMS Therapy can be paid from healthcare flexible spending account. Patients
can also work with Clark Behavioral Health Financing to develop a financing plan,
if needed.
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What do I need to become a NeuroStar TMS Therapy provider?
NeuroStar TMS Therapy can only be prescribed by a licensed psychiatrist and must be administered under a psychiatrist's care and supervision. Also, a
dedicated treatment room is necessary to house the NeuroStar system and administer
daily treatments.
To determine if NeuroStar TMS Therapy is a sound clinical and business decision
for your practice or institution, please call Customer Service at 1-877-600-7555
or
contact us.
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What type of support will Neuronetics provide to new customers?
When you become a NeuroStar TMS Therapy® provider, we will provide you with the tools to ensure success for both you and your patients. We offer
a full range of support services to help you start, manage and grow your TMS Therapy®
facility.
Learn more about our support services.
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References:
- Demitrack MA, Thase, ME. Clinical significance of transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant depression: synthesis of recent data. Psychopharm Bull. 2009, 42(2): 5-38.
- O’Readon, J, et al. Efficacy and Safety of Transcranial Magnetic Stimulation Therapy in the Acute Treatment of Major Depression: A Multi-site Randomized Control Trial. Biological Psychiatry, 2007.
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Refer a Patient for Treatment
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NeuroStar TMS Therapy may be right for your patients suffering from major depression. Refer them here.
Find a Provider
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Become a NeuroStar TMS Therapy Provider
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Provide your patients the new way back from depression with NeuroStar TMS Therapy®.
Contact us to find out how you can bring NeuroStar into your workplace.
Contact Us
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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. Click here for full prescribing and safety information
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