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Microsoft word - 52-40011-000 patient manual.docx

for Transcranial Magnetic Stimulation with the NeuroStar TMS Therapy® System  
This  Depression  Patient’s  Manual  is  a  supplement  to  the  NeuroStar  TMS  System  User  Manual.   It  does  not  take  the  place  of  consultation  and  advice  from  your  physician.  For  a  complete  discussion  of  indications  for  use,  contraindications,  precautions,  warnings,  and  potential  side   effects,  talk  to  your  doctor.  Specifically,  talk  with  your  doctor  about:   Who  should  not  be  treated  with  this  device   Who  can  be  treated  with  this  device   Your  doctor’s  phone  number:   Introduction to NeuroStar TMS Therapy
Effectiveness of NeuroStar TMS Therapy
Your doctor has prescribed NeuroStar TMS Therapy® to reduce the symptoms of The effectiveness of Neurostar TMS Therapy for the treatment of depressed patients - who failed to achieve satisfactory improvement from one prior antidepressant TMS stands for “Transcranial Magnetic Stimulation”. In NeuroStar TMS Therapy, medication at or above the minimal effective dose and duration in the current TMS is delivered by the NeuroStar TMS System as powerful magnetic field pulses. episode - was demonstrated in a retrospective analysis of a 6 week clinical trial. In NeuroStar TMS Therapy has been shown to be safe and effective in the treatment of clinical trials, half of the patients had already received 4 or more antidepressant patients with depression who have failed to achieve satisfactory improvement from medication treatment attempts in their current episode of depression, but only one one prior antidepressant medication at or above the minimal effective dose and antidepressant medication had been given at a high enough dose for a long enough duration in the current episode. NeuroStar TMS Therapy has not been shown to be period of time that it would have been likely to be effective. A retrospective analysis effective for the treatment of patients who have failed 2 or more antidepressant was done for this population because the original study included patients who had medications at or above the minimal effective dose and duration in the current failed to achieve satisfactory improvement from one to four antidepressants episode or who have had no prior antidepressant treatment. Your physician wil use medications, and failed to show that the device was effective in the overal group. a medication checklist to help determine whether or not your antidepressant This trial had one group treated with the NeuroStar TMS device, while another group medication history makes you a potential candidate for NeuroStar TMS Therapy. received an inactive treatment. One hundred sixty-four patients were assigned in a Further details on the medication checklist can be obtained from your provider. random fashion to one of these two groups and received 6 weeks of treatment NeuroStar TMS Therapy is performed in your doctor’s office under his or her care. The primary endpoint was the change from baseline (i.e., the starting score before The treatment is non-invasive and non-systemic which means that it does not treatment) in a standard scale for measuring depression symptoms, known as the involve surgery and does not circulate in the blood stream throughout the body. (Montgomery-Asberg Depression Rating Scale (MADRS). The average baseline Treatment with NeuroStar TMS Therapy does not involve anesthesia or sedation, score in the patient group assigned to treatment with the NeuroStar TMS device was and patients are awake and alert during the treatment session. A typical treatment 32 points, and in the group assigned to treatment with the inactive device was 33 course consists of 5 treatments per week over a 4-6 week period for a total of 20-30 separate treatment sessions. Each treatment session lasts approximately 40 At the end of 4 weeks, the group treated with the NeuroStar TMS device improved minutes. You should discuss the number of treatments and treatment schedule with an average of 7.1 points (an average reduction in score of 22.1%), while the group treated with the inactive device improved an average of 2.1 points (an average NeuroStar TMS Therapy is not an appropriate treatment for al patients with reduction in score of 9%). This difference was statistical y significant. depression. You should review this patient manual and discuss the information with Between weeks 4 and 6, patients could leave the study if they were not responding. your doctor in order to determine if NeuroStar TMS Therapy is an appropriate The overal discontinuation rate through week 4 across both treatment groups was 19 of 164 patients or 11.6%. For each treatment group, the discontinuation rate through week 4 was 11 of 88 patients, or 12.5%, in the active TMS treatment group, How Does NeuroStar TMS Therapy Work?
and 8 of 76 patients, or 10.5%, in the inactive treatment group. At 4 weeks, patients who did not respond to TMS therapy were al owed to exit the study. Twenty-three of During treatment with the NeuroStar TMS System, the NeuroStar treatment “coil” is 88 (26.1%) patients in the active TMS group and 32 of 76 (42.1%) patients in the positioned gently on the left front side of the head over a region of the brain cal ed inactive treatment group exited the study after week 4 due to lack of efficacy. An the Left Prefrontal Cortex. By sending short bursts of electricity through the additional 7 patients exited the study after week 4 across both treatment groups for treatment coil, the NeuroStar TMS System generates magnetic fields that turn on reasons unrelated to efficacy. Therefore, the cumulative overal discontinuation rate and off very rapidly. These magnetic fields are the same type and strength as those through week 6 across both treatment groups was 81 of 164 patients or 49.4%. used in magnetic resonance imaging (MRI) machines. Fol owing completion of this therapy al patients received ongoing treatment with an The rapidly pulsing magnetic fields that are generated by the NeuroStar go directly antidepressant medication. Relapse into depression is likely without fol ow-up through the hair, scalp and skul and create smal electric currents in the area of the treatment. You should discuss long-term treatment planning with your doctor. brain directly under the treatment “coil”. The electric currents created in the brain Further details on the study can be obtained from your treating provider. make nerve cel s in that region become active. Limitations of NeuroStar TMS Therapy
When Can NeuroStar TMS Therapy Be Used?
NeuroStar TMS Therapy has been shown to be safe and effective in the indicated Indications for Use
patient population only. Care should be taken to ensure that NeuroStar TMS Therapy is the right treatment for you. 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 Most patients who benefit from NeuroStar TMS Therapy experience results by the antidepressant medication at or above the minimal effective dose and duration in the fourth week of treatment. Some patients may experience results in less time. NeuroStar TMS Therapy was administered for six weeks so it is unknown whether longer treatment would be effective for your depression. As with any antidepressant, there is a risk of worsening of your depression during When Should NeuroStar TMS Therapy Not Be Used?
treatment with NeuroStar TMS Therapy. Contact your doctor immediately if symptoms persist or worsen. NeuroStar TMS Therapy delivers a magnetic field that could cause any metal objects that are near the device to move or to get hot. The device was shown to be safe and effective in patients who had been able to stop taking their antidepressant medications. If you feel that your depression NeuroStar TMS Therapy should not be used in patients who have magnetic- worsens when you stop your antidepressant medications, contact your doctor sensitive metals implanted in their head or within 12 inches of the NeuroStar This therapy has not been demonstrated to be safe and effective for patients who NeuroStar TMS Therapy should not be used in patients who have an implanted device that may not properly function in the presence of the NeuroStar TMS System, even if the device is located outside this (12 inch) distance. Your doctor wil ask you to list any metal devices or objects in your head or body in order to determine if those devices could be affected by the NeuroStar TMS System. Use of NeuroStar TMS Therapy in the presence of these objects could result in serious injury or death. Standard amalgam dental fil ings are not affected by the magnetic field and are acceptable in patients being considered for treatment with NeuroStar TMS Therapy. NeuroStar TMS Therapy Safety Information
Patients with neurological conditions that include a history of seizure, cerebrovascular disease, dementia, increased intracranial pressure, movement The safety of NeuroStar TMS Therapy was determined in clinical trials of 323 patients disorders, having a history of repetitive or severe head trauma, or with primary with moderate to severe Major Depressive Disorder who ranged in age from 18 to 70 years, and who had failed to achieve satisfactory improvement from prior Patients with metal in or around the head, including metal plates, aneurysm coils, cochlear implants, occular implants, deep brain stimualtion devices and stents. Less than 5% of al patients dropped out of the clinical trial because of side effects from the treatment. Patients with implants control ed by physiological signals, including pacemakers, implantable cardioverter defibril ators, and vagus nerve There were no deaths or seizures in patients who took part in the clinical trial. Systemic side effects such as weight gain, sexual problems, stomach problems, sleepiness, and dry mouth were not observed. Patients with major depressive disorder who have failed to receive clinical benefit from ECT or VNS. Tests of memory function during treatment showed no change during the clinical trial. This section provides information about adverse events observed with the use of the The NeuroStar TMS System produces a loud click with each magnetic pulse, patients NeuroStar TMS System in clinical trials. treated with the NeuroStar TMS System must always wear earplugs or similar hearing protection devices with a rating of 30dB or higher of noise reduction during treatment. Warnings and precautions to be considered prior to receiving NeuroStar TMS In clinical trials, NeuroStar TMS Therapy had no effect on hearing when earplugs Therapy are also provided and should be discussed with your doctor to determine what, if any, precautions should be taken during your treatment with NeuroStar TMS Therapy. The long term effectiveness of NeuroStar TMS Therapy for treating depression has not been evaluated. In clinical studies, NeuroStar TMS Therapy was safely tolerated Worsening Depression or Suicidality
in patients for periods up to 12 continuous weeks, and no negative effects of treatment were seen during a 24-week fol ow-up period. However, effectiveness has Depression is a serious medical il ness. Not al patients treated with an antidepressant wil get better with treatment. Because of this, some patients may not been established for treatment beyond a single six week course. experience worsening of their depression before they begin to see improvement of Longer term effects of exposure to the NeuroStar TMS System magnetic field are not their symptoms. NeuroStar TMS Therapy may require up to 4-6 weeks of treatment known. However, exposure to other devices (such as MRI scanners) with the same before symptom improvement occurs and has not been studied in patients who need type and strength of magnetic fields produced by the NeuroStar TMS System coil are rapid improvement in their depression symptoms. not associated with significant short-term or long-term safety concerns. You should inform your doctor if your symptoms do not improve, or if they get worse. If you have thoughts of death or suicide you should immediately discuss this with your Adverse Events
doctor. Your doctor wil determine whether NeuroStar TMS Therapy should be discontinued and, if so, what other treatment options are available. You should be Temporary pain or discomfort at the area of the head where the treatment coil was careful y monitored for worsening symptoms, signs or symptoms of suicidal behavior placed was reported in about a third of patients who were treated with the NeuroStar and/or unusual behavior. Families and caregivers should also be aware of the need TMS System, while this occurred in less than 5% of patients treated with sham to observe the patient and notify the treatment provider if symptoms worsen. (placebo), suggesting that this is a direct effect of NeuroStar TMS Therapy. Risk of Ineffective Therapy
Inform your doctor if you experience discomfort during treatment. Your doctor can decrease the NeuroStar TMS dose or move the NeuroStar TMS coil slightly to ease NeuroStar TMS Therapy is indicated for patients who have failed to receive or eliminate the discomfort. Treatment site discomfort went away rapidly with time, satisfactory improvement from one prior antidepressant medication given at a high usual y getting better within the first week of treatment. enough dose for a long enough period of time to be effective. In clinical trials, patients had also received additional antidepressant medication attempts in their Headaches were reported by about half of the patients who took part in the clinical current episode of depression, but only one antidepressant had been given at the trial regardless of whether they were treated with real TMS or with the sham (placebo) adequate dose and duration for it to be effective. treatment. In general, the headaches got better over time, and could be relieved by using common over-the-counter pain medications such as acetaminophen. The clinical trial included patients who had failed to achieve satisfactory improvement from one to four antidepressant medications. The device was not demonstrated to be The fol owing table presents a summary of adverse events that occurred in the clinical effective for patients who had failed to benefit from two or more antidepressant trial in ≥5% or more of the patients treated with NeuroStar TMS Therapy and at least medications. Therefore, it is important that your prior antidepressant medication twice as often as was seen in patients treated with sham (placebo) treatment. Safety history is careful y evaluated by your doctor to determine if NeuroStar TMS Therapy is information is provided from al patients who had been treated in the clinical study Other Risks
Seizures (sometimes cal ed convulsions or fits) have been reported with the use of TMS devices. No seizures were observed with use of the NeuroStar TMS System in Table 1. Adverse Events Reported with NeuroStar TMS
clinical trials that included over 10,000 treatment sessions. Since the introduction of Therapy:
the NeuroStar TMS System into clinical practice, seizures have been rarely reported. (Study 101, Incidence with Active TMS > 5%
The estimated risk of seizure under ordinary clinical use is approximately 1 in 30,000 and at Least Twice the Rate with Sham Treatment)
treatments (0.003% of treatments) or 1 in 1000 patients (0.1% of patients). You should discuss with your doctor if you have had a seizure, or if you have a medical condition that you have been told may put you at increased risk of having a seizure. Active  TMS  
Sham  TMS  
Your doctor wil decide if it is appropriate for you to receive NeuroStar TMS Therapy. The safety and effectiveness of NeuroStar TMS Therapy has not been established in Event  Type  
the fol owing patient populations or clinical conditions through a control ed clinical Patients who have failed to receive benefit from 2 or more antidepressant medications given at or above minimal effective dose and duration in the current episode or patients who have had no prior antidepressant medication. Patients who can not tolerate withdrawal of antidepressant medications. Patients who have a suicide plan or have recently attempted suicide Patients with seasonal affective disorder Patients younger than 22 years of age or older than 70 years of age Patients with history of substance abuse, obsessive compulsive disorder or post-traumatic stress disorder. Patients with a psychotic disorder, including schizoaffective disorder, bipolar disease, or major depression with psychotic For more information on TMS, visit the Neuronetics Web site: http://www.NeuroStarTMS.com

Source: http://www.neurostar.co/wp-content/uploads/Depression_Patient_Manual.pdf

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