Full Answer
Is there a user manual for neurostar TMS therapy?
USER MANUAL SUPPLEMENT This supplement provides an overview of NeuroStar TMS Therapy and new clinical data, supporting an expanded indication for use as of March 2014. The information contained here supersedes the “Introduction” and “Summary of Clinical Studies” of the NeuroStar TMS Therapy System User Manual dated prior to April 2014. MAY 2014
How common are seizures with neurostar TMS?
Since the introduction of the NeuroStar TMS Therapy 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 (0.003% of treatments) or 1 in 1000 patients (0.1% of patients).
What is the neurostar study 101?
Study 101 was a randomized sham-controlled clinical trial (RCT) designed to evaluate the safety and efficacy of the NeuroStar TMS Therapy System for the treatment of patients with MDD (N=301) who have failed to receive benefit from 1 to 4 prior antidepressant medications verified by the ATHF.
How many patients have been randomized to TMS treatment?
None of the six patients had been allocated to active TMS treatment; four patients were in the pre- randomization phase of the study and two had been randomized to sham treatment. In Study 101, there were seven patients who were hospitalized following the development of suicidal ideation or a suicide attempt.
How many treatments are needed for TMS?
During a typical course, you'll receive around 36 treatments over a nine week period. You'll undergo five treatment sessions per week for the first six weeks, and then taper down the remaining six sessions over the following three weeks.
Is NeuroStar Deep TMS?
Since the release of the NeuroStar, additional TMS devices have gained FDA approval for depression treatment including: Apollo, Bransway Deep, CloudTMS, Magstim, MagVenture, Neurostar, and Nexstim.
How many treatments does it take for TMS to work?
When does TMS start working for depression? TMS therapy sessions range from 30 to 36 treatments over a 6-9 week period, but when do patients start noticing a change? Because every patient is different, reaction to treatment can vary. Some patients may notice small changes after week 2 and others not until week 4 or 5.
What is NeuroStar advanced therapy?
NeuroStar Advanced Therapy is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
What is the difference between TMS and deep TMS?
Traditional TMS uses a figure-8 coil, while deep TMS uses a patented H-coil held inside a padded helmet. While the magnetic pulses activated by traditional TMS only reach a depth of 0.27” (0.7 cm), deep TMS technology manages to reach a significant sub-threshold of 1.25” (3.2 cm).
Are all TMS treatments the same?
rTMS therapy involves a series of treatment sessions. Treatment sessions vary in length depending on the TMS coil used and the number of pulses delivered but typically last around 30 – 40 minutes. Patients receive TMS 5 days a week. A typical course of rTMS is 4 to 6 weeks.
Does TMS work after one session?
Generally, people are able to return to work or resume normal activities immediately after their sessions. The first cycle of TMS sessions is usually 5 days a week for 4 to 6 weeks. After the first cycle, the sessions will reduce gradually until your mental health care provider recommends you stop.
Does TMS work a second time?
We found that of the four patients who did not respond to a first course of TMS, three responded to a second course. While these numbers are small, they show a second course (following a failed course) may be beneficial.
How long do TMS results last?
Most patients who complete TMS treatment experience relief from symptoms of depression for six months to a year. Your results could also last for more than a year.
What is TMS mapping?
Motor mapping with transcranial magnetic stimulation (TMS) is a non-invasive technique used to probe motor cortical representation in humans. TMS mapping can evaluate features of motor representations and be used to draw conclusions about muscle group somatotopy within the motor cortex.
How is TMS mapping done?
The first day of TMS treatment involves “mapping” of the brain in order to determine the appropriate amount of stimulation and the specific treatment location on your head. A cap is placed on the patient's head. Various measurements are made and specific brain landmarks are marked on the cap.
Can TMS cause brain damage?
No. TMS doesn't cause brain damage. This is assuming that all the screening measures are taken and there are no contraindications to the magnetic treatment (no ferromagnetic metals in the brain).
What is neurostar TMS?
The NeuroStar TMS System is indicated for the treatment of major depressive disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
What is Neurostar study 19-50001?
Study 19-50001 was a multisite naturalistic study in 42 US centers that evalu-ated the acute efficacy and 12-month durability of NeuroStar TMS Therapy under conditions of general clinical use (Carpenter, et al, 2012, Janicak, et al., 2013). The study enrolled adult patients (N=307) with MDD who failed to benefit from any number of antidepressant medications administered at an adequate dose and duration (mean of 2.5, range 0-14) in the current episode.
Why are safety analyses performed in the study 101?
Because a risk of disease worsening is inherent in the treatment of major depression, specific safety analyses were performed to define further the incidence of disease worsening or the risk of emergent suicidal ideation in the study population. These analyses were conducted for the randomized controlled Study 101, where a direct comparison to the background sham treatment condition could be performed.
What is study 101?
Study 101 was a randomized sham-controlled clinical trial (RCT) designed to evaluate the safety and efficacy of the NeuroStar TMS Therapy System for the treatment of patients with MDD (N=301) who have failed to receive benefit from 1 to 4 prior antidepressant medications verified by the ATHF. Patients meeting ATHF 1 criteria comprised the majority of the overall study population (N=164, 54.5% of the total study population).
Can you get neurostar TMS from a coil?
Patients who have implanted devices or metallic objects located in areas outside the 30 cm distance from the treatment coil may receive NeuroStar TMS Therapy. However, care must be taken by the NeuroStar TMS Therapy System operator to ensure that the treatment coil is never placed within 30 cm of these implants. Otherwise, serious injury could result. (Examples of these devices include staples and implanted insulin pumps.)
Can Neurostar be used with caution?
The NeuroStar TMS Therapy System should be used only with caution in the situations identified below. All patients must be screened for the conditions noted and appropriate cautionary measures should be taken.
Can Neurostar TMS cause seizures?
Generalized seizures have been reported with the use of TMS in the clinical trial literature. No seizures were reported with use of the NeuroStar TMS Therapy System in over 10,000 treatment sessions in trials conducted prior to FDA clearance of the NeuroStar TMS Therapy System. Since the introduction of the NeuroStar TMS Therapy 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 (0.003% of treatments) or 1 in 1000 patients (0.1% of patients). Nevertheless, the NeuroStar TMS Therapy System should be used with caution in patients who have a history of seizures, or a potential for alteration in seizure threshold, as stated below.
What is NeuroStar TMS Therapy?
FDA cleared in 2008, NeuroStar Advanced Therapy is a non-drug, non-invasive treatment that uses magnetic pulses to stimulate areas of the brain that are underactive in depression –otherwise known as transcranial magnetic stimulation (TMS), which is different than electroconvulsive therapy (ECT).
Neurostar TMS Therapy Process
During NeuroStar Advance Therapy, the treating clinician positions the treatment coil over the left prefrontal cortex, an area of the brain known to affect mood.
Minimal Side Effects of TMS
NeuroStar Advanced Therapy provides benefits without the side effects often associated with antidepressant medication or ECT. The most common side effect is pain or discomfort at or near the treatment site. Unlike TMS, ECT involves general anesthesia and is considered an invasive treatment.
TMS Therapy can be Effective When Other Treatments Are Not
TMS therapy is indicated for adult patients with Major Depressive Disorder who have not seen success with at least one antidepressant. Depression is known to have genetic and psychological causes that involve the brain. The risk factors, such as hormonal changes and medication use, vary widely with each person.
Length of TMS Treatments
NeuroStar treatments occur 5 days per week and can be completed in as little as 19 minutes. The entire process lasts an average of 4-6 weeks. In some cases, a repeat treatment of TMS (rTMS) may be needed.
How long does neurostar TMS treatment last?
A standard treatment course for depression consists of 5 treatment sessions per week for 4 to 6 weeks, depending on patient response. Each NeuroStar TMS treatment is performed under continuous medical observation which results in high patient adherence.
What is TMS therapy?
TMS Therapy is a therapeutic neuromodulation technique used for the treatment of patients with major depression. TMS is a noninvasive, non-systemic therapy that uses MRI-strength, pulsed, magnetic fields to induce an electric current in a localized region of the cerebral cortex. Sufficiently intense magnetic fields induce an electric current, which then causes depolarization of cortical neurons in a localized region of the brain immediately underneath the stimulation coil. Because the superficial cerebral cortex has extensive, trans-synaptic interconnections to deeper brain structures, this local depolarization leads to concurrent activation of brain regions distant from the site of stimulation. When applied to the left dorsolateral prefrontal cortex, TMS Therapy works in a targeted fashion directly on the neurocircuitry thought to control mood. Accumulating evidence suggests that repeated daily TMS sessions cause enduring changes in both brain function and clinical behavior3. Preclinical evidence has established that TMS exerts effects in animal models consistent with known effective antidepressant treatments4. When used as an antidepressant therapy, TMS produces a sustained clinical benefit without the systemic side effects typical with oral medications and has no adverse effects on cognition5,6.
When was TMS cleared?
In October 2008, the US Food and Drug Administration cleared TMS Therapy, delivered by the NeuroStar TMS Therapy system manufactured by Neuronetics, Inc., “for the treatment of major depression in adult patients who failed to achieve satisfactory improvement from one prior antidepressant medication of adequate dose and duration in the current episode”. FDA clearance was based on a registration clinical trial program that included the largest multicenter, randomized, controlled trial of TMS in major depression5,7 as well as efficacy and durability open-label trials7,8.
Is Neurostar TMS safe?
In summary, support for the use of NeuroStar TMS Therapy as a proven, safe and effective treatment for patients with major depression can be found in the published scientific literature, by the supportive statements of expert consensus treatment guidelines, and in the increasing acceptance by practicing physicians and payers.
What is TMS therapy?
TMS stands for transcranial magnetic stimulation. It is used to treat depression by stimulating the brain non-invasively using electromagnetic fields, similar to those produced by an MRI machine. During TMS Therapy, a magnetic field is administered in very short pulses to the part of the brain that research has demonstrated to be associated ...
Does Neurostar cause weight gain?
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, etc. The most common side effects reported during clinical trials were headache and scalp discomfort – generally mild to moderate – occurring less frequently after the first week of treatment.
Is Neurostar TMS safe?
Clinical trials have demonstrated the safety and effectiveness of NeuroStar® TMS Therapy in treating patients who have not benefited from prior antidepressant medication. NeuroStar TMS Therapy was studied in adult patients suffering from Major Depressive Disorder, all of whom had not received satisfactory improvement with previous treatments.
What is neurostar TMS?
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 .
How much does Neurostar TMS therapy reduce depression?
In a controlled clinical trial comparing active treatment with the NeuroStar TMS Therapy® system to an inactive device, patients treated with active NeuroStar TMS Therapy experienced a 22.1% average reduction of their depression symptoms, compared to a 9% average reduction of depression symptoms in patients receiving inactive treatment.1
What is the magnetic field of neurostar?
The NeuroStar TMS System treatment coil produces strong-pulsed magnetic fields, which can affect certain implanted devices or objects. The magnetic field strength diminishes quickly with increasing distance from the coil. Within 30 cm of the face of the treatment coil, the peak magnetic field can be greater than 5 Gauss, which is the recommended static magnetic field exclusion level for many electronic devices.
Can you get neurostar TMS from a coil?
Patients who have implanted devices or metallic objects located in areas outside the 30 cm distance from the treatment coil may receive NeuroStar TMS Therapy. However, care must be taken by the NeuroStar TMS System operator to ensure that the treatment coil is never placed within 30 cm of these implants. Otherwise, serious injury could result. [Examples of these devices include staples, implanted insulin pumps, and vagus nerve stimulators (VNS).]
Can Neurostar be used with caution?
The NeuroStar TMS System should be used only with caution in the situations identified below. All patients must be screened for the conditions noted and appropriate cautionary measures should be taken.
Is Neurostar TMS therapy safe?
NeuroStar TMS Therapy has not been evaluated in patients with psychoses or with psychiatric emergencies where a rapid clinical response is needed, such as marked physical deterioration, catatonia, or immediate suicide risk. Use of NeuroStar TMS Therapy in the treatment of these patients is not recommended since rapid onset of effect in these high-risk populations has not been established.
Is Neurostar TMS contraindicated?
The NeuroStar TMS System is contraindicated for use in some situations as identified below and further described in Volume 2, Section 2. All patients must be screened for the following contraindications.
Where is Neurostar TMS?
NeuroStar TMS therapy is provided at our California locations in Carlsbad, Mission Valley, and Riverside centers, and in Alaska at Anchorage and Wasilla centers. Patient remain awake and alert during TMS therapy, and a treatment session takes anywhere from 19 to 37 minutes to complete.
Where is the TMS placed on the head?
Before NeuroStar TMS is performed, a patient is seated comfortably in a treatment chair, and a small, magnetic coil is placed on the head, near the left temple. Treatment begins when focused magnetic stimulation is sent to specific areas of each patient’s brain. At this time, the patient may experience a tapping sensation on the head and hear a clicking sound.
What insurances use transcranial magnetic stimulation?
Insurances that we’re in network with include Cigna, Anthem Blue Cross, Magellan, Tricare, Blue Shield of CA, Blue Shield Federal Employee, Optum, Aetna, MHN, Healthnet, Beacon , Prime Health Services, Provider Select, Medicare, Providence Preferred, Providence Health Plan, Regence Blue Cross Blue Shield, First Choice Health Network, First Health National Network, Pacificsource, Moda, OHA (fee for service only), First Health, and Premera Blue Cross. Please call us for a full list of providers. We would be happy to help check with your insurance regarding pre-approval.
How long does it take for TMS to go away?
Researchers indicated this effect usually disappeared on its own within about one week of treatment.
Can Neurostar help with depression?
Patients who find that depression interferes with their ability to perform daily activities may benefit from NeuroStar TMS. Further, patients who previously tried antidepressants or other depression therapies but experienced intolerable side effects or did not achieve the optimal results may benefit from this type of TMS therapy as well.
Can you drive after TMS?
After TMS therapy is finished, patients can resume normal daily activities. There are no systemic side effects and patients can drive resume normal daily activities after each treatment session.
Is Neurostar a prescription?
NeuroStar is a prescription-only and FDA-cleared TMS therapy that involves the use of a targeted, pulsed magnetic field that is similar to one used in a magnetic resonance imaging (MRI) scan. TMS therapy is noninvasive, does not require the use of drugs, and may help deliver long-lasting depression symptom relief.