Name: The NeuroStar TMS Device: Conducting the FDA Approved Protocol for Treatment of Depression (Video) | JoVE Journal
Uploaded: 2010-11-12T17:00:00.000+00:00
Duration: 10 min 29 s
Description: Learn the FDA approved NeuroStar TMS protocol for treating medication-resistant major depression. This video demonstrates patient preparation, motor threshold determination, and stimulation procedures for effective non-invasive therapy.

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5 minutes

1) Preparation
<ol>
	<li>To begin, start up the NeuroStar system, log in, and perform the automated coil test.</li>
	<li>Next, access the appropriate patient file from the available list (all patients treated using the NeuroStar system are logged into the central computer)</li>
	<li>Finally, ensure the chair settings are not restrictive and lift the chair arm to make it easy for the patient to enter and sit down.</li>
</ol>
2) Seating and Aligning the Patient
<ol>
	<li>When the patient arrives, seat him/her comfortably in the chair.</li>
	<li>Make sure both the patient and the technician insert ear plugs.</li>
	<li>Using the adhesive strip, attach the head positioning strap just above the patient's eyebrows. Make sure the central point is located above the nasion.</li>
	<li>Recline the chair and adjust the head support as needed.</li>
	<li>Lightly attach the top head strap to the Velcro above the patient's nasion.</li>
	<li>Activate the laser and ensure it bisects the patient's nasion.</li>
	<li>Ask the subject to stare at a point on the wall and adjust the A/P bar until it is level with the eyeballs.</li>
	<li>Ensure the patient is fully centered and use the Velcro to secure the side head positioning straps to the treatment chair.</li>
	<li>Lightly engage the side head pad to ensure cranial stability during motor threshold determination.</li>
	<li>Finally, record the head support system settings using the touch screen interface.</li>
</ol>
3) Determine Motor Threshold
<ol>
	<li>To determine motor threshold, move the coil down to the patient's head such that the coil is at the vertex and the SenStar tab is aligned above the top of the ear.</li>
	<li>Move the A/P bar forward until it aligns with the side of the coil.</li>
	<li>Align the center line on the coil with the 0 degree mark on the coil angle indicator and move back the A/P bar.</li>
	<li>Once contact and position have been established, ask the subject to enact the hitchhiker position: arm bent 90 degrees at the elbow, fist held loosely, thumb extended outwards.</li>
	<li>Begin stimulation and focus on any movement of the thumb.</li>
	<li>Gradually increase the MT level from 0.68 to 1.10 until thumb or concordant finger movement is seen.</li>
	<li>Once movement is established, begin searching for the motor hotspot. Move the coil around in a grid like pattern, adjusting the MT level as needed. Continue this search until you find a location and power level setting that elicits exactly 5 thumb twitches out of 10 consecutive pulses.</li>
	<li>Once the motor hotspot has been determined, move the A/P bar forward until it, once again, aligns with the side of the coil.</li>
	<li>Use the touch screen interface to record the A/P position, Coil Angle, SOA position, and Power Level.</li>
	<li>Finally, press the Found MT button. We are now ready for treatment.</li>
</ol>
4) Patient Treatment
<ol>
	<li>To begin, move the coil 5.5 cm anterior to the MT location. This will be the treatment location.</li>
	<li>Ensure the coil is making contact with the patient's head and ask the patient to remain still for the duration of the treatment.</li>
	<li>The treatment parameters are preloaded into the device. Stimulation will be generated at 120% motor threshold with a pulse sequence of 10 Hz for 4 seconds, followed by a 26 second quiet period. Treatment will last for a total of 37.5 minutes this is a total of 3,000 pulses.</li>
	<li>Press the Confirm Pulse Sequence button then press the Start button.</li>
	<li>During treatment, remain in the room with the patient and periodically check to ensure the coil is making contact with the patient.</li>
	<li>After the pulse sequence is completed, move the coil up and away from the patient's head and move away the side head support pad.</li>
	<li>Raise the back of the chair and raise the arm of the chair.</li>
	<li>Assist the patient as he/she stands up.</li>
	<li>Remove ear plugs and touch the Logout button to end the treatment session.</li>
</ol>
5) Representative Results
TMS is typically applied daily for a period of 4-6 weeks. Recent data suggests some patients may be prone to symptomatic relapse after 4-6 months.8 If this occurs, practitioners may want to consider maintenance sessions to prolong effect. This treatment has been effective in approximately 60% of the patients treated.
<img src="/files/ftp_upload/2345/2345fig1.jpg" alt="NeuroStar TMS therapy results; HAMD-24 response and remission rates chart; statistical analysis." data-altupdatedat="1788235205000" data-alt="Table 5">

<ol><li>Pascual-Leone, A., Davey, M., Wassermann, E. M., Rothwell, J., Puri, B. <a target="_blank" href="http://scholar.google.com/scholar?hl=en&safe=off&q=author%3aPascual-Leone%2C+A+%22Handbook+of+Transcranial+Magnetic+Stimulation%22">Handbook of Transcranial Magnetic Stimulation</a>. , Edward Arnold. London. (2002).</li>
<li>Walsh, V., Pascual-Leone, A. <a target="_blank" href="http://scholar.google.com/scholar?hl=en&safe=off&q=author%3aWalsh%2C+V+%22Transcranial+Magnetic+Stimulation%3A+A+Neurochronometrics+of+Mind%22">Transcranial Magnetic Stimulation: A Neurochronometrics of Mind</a>. , MIT Press. Cambridge. (2005).</li>
<li>Horvath, J. C., Perez, J., Forrow, L., Fregni, F., Pascual-Leone, A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Transcranial+Magnetic+Stimulation%3A+An+Historical+Evaluation+and+Future+Prognosis+of+Therapeutically+Relevant+Ethical+Concerns%5BTitle%5D)+AND+%22%22%5BJournal%5D)">Transcranial Magnetic Stimulation: An Historical Evaluation and Future Prognosis of Therapeutically Relevant Ethical Concerns.</a> , Forthcoming Forthcoming.</li>
<li>O'Reardon, J. P., Solvason, H. B., Janicak, P. G., Sampson, S., Isenberg, K. E., Nahas, Z., McDonald, W. M., Avery, D., Fitzgerald, P. B., Loo, C., Demitrack, M. A., George, M. S., Sackheim, H. A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Efficacy+and+safety+of+transcranial+magnetic+stimulation+in+the+acute+treatment+of+major+depression%3A+a+multisite+randomized+control+trial%5BTitle%5D)+AND+%22Biological+Psychiatry%22%5BJournal%5D)">Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized control trial.</a> Biological Psychiatry. 62, 1208-1216 (2007).</li>
<li>George, M. S., Lisanby, S. H., Avery, D., McDonald, W. M., Durkalski, V., Pavlicova, M., Anderson, B., Nahas, Z., Bulow, P., Zarkowski, P., Holtzheimer, P. D., Schwartz, T., Sackheim, H. A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Daily+prefrontal+transcranial+magnetic+stimulation+therapy+for+major+depressive+disorder%3A+a+sham-controlled+randomized+study%5BTitle%5D)+AND+%22Arch+Gen+Psychiatry%22%5BJournal%5D)">Daily prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized study.</a> Arch Gen Psychiatry. 67, 507-516 (2010).</li>
<li>Lisanbym, S. H., Husain, M. M. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Daily+Left+Prefrontal+Repetitive+Transcranial+Magnetic+Stimulation+%28rTMS%29+in+the+Acute+Treatment+of+Major+Depression%3A+Clinical+Predictors+of+Outcome+in+a+Multisite%2C+Randomized+Controlled+Clinical+Trial%5BTitle%5D)+AND+%22Neuropsychopharmacology%22%5BJournal%5D)">Daily Left Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS) in the Acute Treatment of Major Depression: Clinical Predictors of Outcome in a Multisite, Randomized Controlled Clinical Trial.</a> Neuropsychopharmacology. 34, 522-534 (2008).</li>
<li>Thase, M., Demitrack, M. A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Evaluating+clinical+significance+of+treatment+outcomes+in+studies+of+resistant+major+depression%5BTitle%5D)+AND+%22Biological+Psychiatry%22%5BJournal%5D)">Evaluating clinical significance of treatment outcomes in studies of resistant major depression.</a> Biological Psychiatry. 63, 138-138 (2008).</li>
<li>Demirtas-Tatlidede, A., Mechanic-Hamilton, D., Press, D. Z., Pearlman, C., Stern, W. M., Thall, M., Pascual-Leone, A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((An+open-label%2C+prospective+study+of+repetitive+transcranial+magnetic+stimulation+%28rTMS%29+in+the+long-term+treatment+of+refractory+depression%3A+reproducibility+and+duration+of+the+antidepressant+effect+in+medication-free+patients%5BTitle%5D)+AND+%22Journal+of+Clinical+Psychiatry%22%5BJournal%5D)">An open-label, prospective study of repetitive transcranial magnetic stimulation (rTMS) in the long-term treatment of refractory depression: reproducibility and duration of the antidepressant effect in medication-free patients.</a> Journal of Clinical Psychiatry. 69, 930-934 (2008).</li>
</ol>

The video production of this article was sponsored by Neuronetics, which produces instruments used in these studies.

When considering TMS as a potential therapeutic intervention for depression, it is important to recognize the FDA approved protocol is highly specified. To be concrete, FDA approval is limited to 10 Hz suprathreshold stimulation applied daily for 4-6 weeks using the NeuroStar device upon patients who have failed to achieve satisfactory improvement from one, but no more than one, adequate antidepressant medication trials during the current depressive episode. At this point, utilization of any alternate stimulation pattern, alternate time course, alternate device, or alternate patient population is considered off-label.
As results continue to be generated in support of the efficacy of TMS treatment5,6,7, new data is revealing the possibility of symptomatic relapse occurring 4-6 months after treatment cessation. As of this publication, there are no approved maintenance protocols. Therefore, issues concerning additional treatment and/or effect maintenance must be considered and monitored closely by individual practitioners.

<table><tbody><tr><td>Neuronetics Neurostar TMS Device</td><td></td><td></td><td></td></tr><tr><td>SenStar Treatment Link</td><td></td><td></td><td></td></tr><tr><td>Ear Plugs</td><td></td><td></td><td></td></tr><tr><td>Head Pad Sanitary Sheets</td><td></td><td></td><td></td></tr><tr><td>Alignment Head Strap</td><td></td><td></td><td></td></tr><tr><td>Motor Threshold Arm Position Pad</td><td></td><td></td><td></td></tr></tbody></table>

the neurostar tms device: conducting the fda approved protocol for treatment of depression

The NeuroStar TMS Device: Conducting the FDA Approved Protocol for Treatment of Depression

The Neuronetics NeuroStar Transcranial Magnetic Stimulation (TMS) System is a class II medical device that produces brief duration, pulsed magnetic fields. These rapidly alternating fields induce electrical currents within localized, targeted regions of the cortex which are associated with various physiological and functional brain changes.1,2,3
In 2007, O'Reardon et al., utilizing the NeuroStar device, published the results of an industry-sponsored, multisite, randomized, sham-stimulation controlled clinical trial in which 301 patients with major depression, who had previously failed to respond to at least one adequate antidepressant treatment trial, underwent either active or sham TMS over the left dorsolateral prefrontal cortex (DLPFC). The patients, who were medication-free at the time of the study, received TMS five times per week over 4-6 weeks.4
The results demonstrated that a sub-population of patients (those who were relatively less resistant to medication, having failed not more than two good pharmacologic trials) showed a statistically significant improvement on the Montgomery-Asberg Depression Scale (MADRS), the Hamilton Depression Rating Scale (HAMD), and various other outcome measures. In October 2008, supported by these and other similar results5,6,7, Neuronetics obtained the first and only Food and Drug Administration (FDA) approval for the clinical treatment of a specific form of medication-refractory depression using a TMS Therapy device (FDA approval K061053).
In this paper, we will explore the specified FDA approved NeuroStar depression treatment protocol (to be administered only under prescription and by a licensed medical profession in either an in- or outpatient setting).

In this article, we examine the methodology and considerations relevant to the FDA approved depression treatment protocol using the Neuronetics NeuroStar TMS device.

The Neuronetics NeuroStar Transcranial Magnetic Stimulation (TMS) System is a class II medical device that produces brief duration, pulsed magnetic ...

The overall goal of this procedure is to examine the procedure and considerations relevant to the FDA cleared depression treatment protocol using the neurotics NeuroStar TMS therapy system. This is accomplished by first prepping the machine and accessing any patient related settings and material. The second step of the procedure is to seat the patient and align the equipment with his or her particular physique.The third step of the procedure is to determine the patient's motor threshold. The final step of the procedure is to stimulate according to the FDA approved parameters. Ultimately, results can be obtained that show a significant decrease in the discomfort and severity of several symptoms of antidepressant medication resistant major depression through four to six weeks of treatment using the NeuroStar TMS therapy system, The implications of this technique extend towards the therapy of antidepressant, medication resistant depression as defined by the FDA clearance of the NeuroStar TMS therapy system.Begin preparation for the session before the patient arrives for treatment by first turning on the NeuroStar system, then use the touchscreen display to log in at the prompt. Also, attach the Send star treatment link to the stimulation coil and perform the automated coil test. Next, access the appropriate patient file from the available list.All patients treated using the NeuroStar system are entered into the central computer system. If this is the first session for a new patient, create a new patient file. After ensuring the patient complies with your unique screening procedure and protocol, shift the side head pad away from the headrest.Raise the gantry arm. Ensure that the AP bar is fully posterior and lift the chair arm to make it easy for the patient to enter and sit down. Finally, cover the headrest and side pad with the supplied disposable covers.When the patient arrives, allow him or her to sit on the side of the treatment chair. If this is the first session, take a moment to introduce him or her to the TMS Coil and treatment chair. Describe the sounds and sensations they may experience during the session.Next, attach the head positioning strap just above the patient's eyebrows using the adhesive strip. Make sure the central point is located above the nasion. At this point, both the patient and the technician operating the system should insert earplugs for hearing protection.As the TMS pulses generate a loud clicking sound, ask the patient to swing their legs around and sit centered in the treatment chair. Lower the arm armrest, recline the chair and adjust the head support as needed. To keep your patient comfortable, lightly attach the top head strap to the Velcro on the head positioning strap above the patient's nasion.Now the patient's head should be aligned so that anatomical landmarks and stimulation targets can be located. Center the patient's head using the positioning laser so that the AP bar bisects the center of the head strap at the patient's nasion. Ask the patient to stare at a point on the wall while you move the AP bar to its full lateral position and adjust the laser to the patient's lateral canthus.Once you ensure that the patient is fully centered and comfortable, use the Velcro to secure the side head positioning straps to the treatment chair. Also, lightly engage the side head pad to ensure that the patient's head remains stable during the rest of the session. Finally, enter the head positioning parameters into the system prior to treatment.It is necessary to determine each patient's resting motor threshold so that the correct stimulation intensity can be set by the system. To do this, adjustments should be made so that the stimulating coil is over the primary motor cortex. Here we are targeting the left motor cortex, but treatment side may vary.Move the stimulating coil down and against the patient's head such that the coil is positioned at the cranial vertex. Confirm that the send star tab on the coil is aligned above the top of the patient's ear. Next, set the superior oblique angle or SOA to 30 degrees and move the AP bar forward until it aligns with the side of the coil.Adjust the coil angle guide if needed and align the sensor line on the coil with the zero degree mark on the AP bar's coil angle indicator, which is indicated by a bolded line. Once coil contact and position settings have been established, ask the subject to enact the hitchhiker position. The right arm should be bent to 90 degrees at the elbow, the fist held loosely and the thumb extended outwards.Ask the patient to relax and begin stimulation while watching the thumb fingers. For any movement. Gradually increase the MT level from 0.68 to 1.30 until thumb or concordant finger muscle twitches are seen.Once movement is established, note the location of the coil, including SOA AP and coil angle, and begins searching on the anterior posterior plane for the strongest and most consistent finger thumb movement. Now from this AP position, move the coil along the SOA angle to continue searching until you find a single location that isolates thumb muscle twitches. After this motor hotspot has been located, use the touchscreen interface to record the SOA position, AP position, and coil angle settings In the system, press the found MT location button indicating that you have determined the location of the patient's primary motor cortex thumb area.These coordinates are saved in the system and the motor threshold or empty level determination can commence adjust the patient's right hand so that the fingers and thumb are relaxed and dangling from the corner of the positioning pad. Now, use the empty assist feature in the NeuroStar system and answer the question, do you see a twitch by touching the yes or no button? After each stimulation delivered by the system, periodically ask the patient to stretch and wiggle their fingers after stimulation.During this process, after the fourth stimulation pass series, the system will determine the patient's empty level. This is defined as the level at which 50%of the pulses would elicit a twitch. Finally, touch the SAVET button to save this setting.Before starting stimulation, the coil must first be moved from the motor cortex to the treatment location, the left dorsal lateral prefrontal cortex. The NeuroStar system will automatically add 5.5 centimeters to the MT location and display the treatment coordinates on the popup screen. Move the coil to the treatment location displayed and confirm the treatment parameters which are preloaded into the device.Stimulation will be generated at 120%motor threshold with a pulse sequence of 10 pulses per second for four seconds, followed by a 26 second interval quiet period. Ensure the coil is making contact with the patient's head as displayed by the green dots on the touchscreen, adjusting the gantry arm as needed. Let the patient know that the stimulation is about to begin and to relax and remain still for the duration of the treatment.Now press the confirm pulse sequence button and then the start button During treatment, remain in the room and periodically check to ensure the coil is making contact with the patient as displayed by the green dots on the touch screen and the green bars on the treatment graph. With the preloaded settings, treatment will last for a total of 37.5 minutes for a total of 3000 TMS pulses. After the pulse sequence is completed, move the coil up and away from the patient's head.Move away the side head support pad. Remove the head positioning straps and allow the patient to remove the earplugs. Raise the back of the chair so that the patient is upright and raise the arm of the chair.Allow the patient to sit for a moment if needed, and provide assistance as he or she stands up. Finally, press the logout button to end the treatment session to treat patients with the neurones NeuroStar TMS device. TMS is typically applied in daily sessions five days a week for a period of four to six weeks following the protocol just seen Once mastered.This daily treatment technique can be done in 45 minutes if performed properly.

the-neurostar-tms-device-conducting-fda-approved-protocol-for

Research

JoVE Journal

Neuroscience

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The present protocol describes the application of repetitive transcranial magnetic stimulation (rTMS), where a subregion of the dorsolateral prefrontal cortex (DLPFC) with the strongest functional anticorrelation with the subgenual anterior cingulate cortex (sgACC) was located as the stimulation target under the assistance of a fMRI-based neuronavigation system.

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Conventional Repetitive Transcranial Magnetic Stimulation for Depression: A Step-by-Step Protocol

This protocol describes the workflow of robotically delivered fMRI-guided personalized transcranial magnetic stimulation therapy for treatment-resistant depression. Clinical implementation using this protocol is feasible, and open-label results support the real-world effectiveness of this approach.

Robotically Delivered fMRI-Guided Personalized Transcranial Magnetic Stimulation Therapy for Treatment-Resistant Depression

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Learn the FDA approved NeuroStar TMS protocol for treating medication-resistant major depression. This video demonstrates patient preparation, motor threshold determination, and stimulation procedures for effective non-invasive therapy.

The NeuroStar TMS Device: Conducting the FDA Approved Protocol for Treatment of Depression

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