After 6 months of clinical use, we are even more convinced that our decision to go with Nexstim for treatment of our patients with refractory depression, was the correct one.
We have been very impressed with the navigated Nexstim NBT® System which is clearly an advance on the brain stimulation systems we have used previously during the past 20 years.
Use of navigated rTMS has the potential for a significant increase in treatment efficacy compared to non-navigated rTMS. Navigation is specifically helpful for target stimulation over the DLPFC, but also to stimulate the various regions of the motor cortical area with anatomical and functional relevance.
INDICATIONS FOR USE
FDA IFU: Nexstim Navigated Brain Therapy (NBT) System 2 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
CE mark : Nexstim Navigated Brain Therapy System for depression is intended to be used for treatment of major depressive disorder (MDD) by targeting and delivering noninvasive repetitive TMS stimulation to the patient's dorsolateral prefrontal cortex.
NBT THERAPY SHOULD NOT BE GIVEN TO
- Patients with non-removable conductive, ferromagnetic, or other magnetic-sensitive metal anywhere in the head or within 30 cm (12 in) of the stimulation coil. Examples include cochlear implants, implanted electrodes or stimulators, aneurysm clips or coils, stents, bullet fragments, ocular implants, and stents.
- Patients who have an active or inactive implanted device (including device leads), including deep brain stimulators, cochlear implants, cardiac pacemakers, and vagus nerve stimulators. Contraindicated use could result in serious injury or death.
- Patients with increased intracranial pressure or patients with intracardiac lines, intravenous pumps, or dose calculators.
Failure to follow these restrictions could result in serious injury or death.
RISKS AND SIDE EFFECTS
Seizures (convulsions): Cortical magnetic stimulation runs the risk of inducing seizures; although they are rare. Under ordinary clinical use, the estimated risk of seizure is approximately 1 in 30 000 treatments (0.003%) or 1 in 1000 patients (0.1%).
Headache: The most common side effects reported during clinical trials are mild headache (~50% of TMS treatment group) and scalp pain or discomfort (35.8%). In general, headache and pain on the stimulation site have been generally mild to moderate and occurring less frequently after the first week of treatment. The reason for headache may be the tension of scalp and neck muscles due to an uncomfortable and stressful situation.
Muscle Twitching: You may feel twitches in the muscles of your arm, leg or face during the magnetic stimulation. This is a common sensation but not hazardous. The twitches will stop when the magnetic stimulation stops.
Skin Irritation: There is a small risk of mild skin irritation at the location where the muscle electrode sensors have been placed, but this usually consists of minor redness that will go away quickly after they are removed.
Changes in hearing: The loud “click” produced by the TMS stimulator can cause temporary hearing changes following treatment. This is prevented by wearing soft foam ear plugs during treatment. No problems with hearing due to TMS have ever occurred when earplugs have been properly worn
There is no evidence that single therapy sessions would improve mood. rTMS treatment effects in reducing depression are temporary, and patients may need to continue other forms of depression therapy. Relapse into depression is likely without follow-up treatment. Notify your doctor in case of worsening depression or suicidality.
CAUTION: SPECIAL POPULATIONS
All patients must be screened for the characteristics listed in this section and excluded without clear benefit or compelling clinical reason.
The safety and effectiveness of Nexstim TMS treatment has not been established in the following patient populations:
- Younger than 22 years or older than 70 years
- Suicide plan or recent suicide attempt
- History of concurrent use of electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS)
- Depression secondary to a general medical condition or substance-induced
- Seasonal affective disorder
- History of substance abuse, obsessive compulsive disorder, or post-traumatic stress disorder
- A psychotic disorder, including schizoaffective disorder, bipolar disorder, or major depression with psychotic features
- History of increased intracranial pressure or head trauma
- Cardiac pacemakers, implantable cardioverter defibrillators, ocular implants, deep brain stimulators, vagus nerve stimulators, implanted medication pumps, intracardiac lines, or significant cardiac disease
- Pregnant or nursing
10 Hz bursts of 40 pulses (one burst is of 4 s duration)
One burst every 30 s, interval of 26 s
Total pulses in a sequence: 3,000
Total sequence duration: 18.8.-37.5 min
50 Hz bursts of 3 pulses
5 burst per second, duration 2 seconds, 8 seconds interval
Total pulses in a sequence: 600
Total sequence duration: 3min 17s
The intensity of the output of the stimulator should be set by operator to 120 % of the resting motor threshold (rMT) of the individual patient’s cortex. A patient’s rMT is determined in a two-step process.
First, single-pulse mapping of the primary motor cortex is used to find the coil location and orientation—the “hotspot”— giving the maximal EMG amplitude in the APB-muscle abductor pollicis brevis (APB) of the left thumb.
Second, targeting the hotspot, the operator uses Nexstim’s proprietary software-assisted stimulation sequence to determine the patient’s rMT. The NBT System software defines the rMT as the lowest level of stimulator output needed to elicit a >50 µV MEP response (peak-to-peak) in the muscle, as observed on EMG, 50% of the time from 10 stimuli.
It is important that the patient is fully relaxed during rMT finding and does not voluntarily activate (move) the hand or arm muscles.
Re-measurement of motor threshold
Re-measurement of rMT may be required if the treating physician suspects that the patient’s cortical excitability has changed. Since the patient’s individual hotspot is one of the patient’s vital parameters stored by the NBT System, rMT re-measurement is a rapid procedure offering a reliable result for intra-patient comparison.
Caution on special conditions and populations
The safety and effectiveness of the NBT System has not been established in the following patient special populations or clinical conditions.
- Patients who have had no prior antidepressant medication failure.
- 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 a 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 features.
- Patients with neurological conditions that include a history of seizures, cerebrovascular disease, dementia, movement disorders, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the CNS.
- Patients with metal in or around the head, including metal plates, aneurysm coils, cochlear implants, ocular implants, deep brain stimulation devices and stents.
- Patients with vagus nerve stimulators (VNS) or implants controlled by physiologic signals, including pacemakers, and implantable cardioverter defibrillators.
- Patients with major depressive disorder who have failed to receive clinical benefit from electro-convulsive therapy (ECT) or VNS.
- Patients who are pregnant or nursing.