Nexstim Podium

The Nexstim Navigated Brain Stimulation (NBS) System 5 is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The Nexstim NBS System 5 provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning.

Nexstim NexSpeech^®, when used together with the NBS System 5, is indicated for non-invasive localization of cortical areas that do not contain essential speech function. NexSpeech^® provides information that may be used in pre-surgical planning in patients undergoing brain surgery. Intra-operatively, the localization information provided by NexSpeech^® is intended to be verified by direct cortical stimulation.

The Nexstim NBS System 5 and NBS System 5 with NexSpeech^® are not intended to be used during a surgical procedure.

The Nexstim NBS System 5 and NBS System 5 with NexSpeech^® are intended to be used by trained clinical professionals.

INDICATIONS FOR USE

CE mark and FDA clearance (K170902, K182700): Nexstim NBS 6 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.

NBS 6 THERAPY SHOULD NOT BE GIVEN TO

1. 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.
2. 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.
3. 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

INEFFECTIVE TREATMENT

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

Nexstim NBS 6 is not approved by the Food and Drug Administration for commercial use of the treatment of chronic pain in the United States, for investigational use only.

CE mark Intended use

Nexstim NBS 6 for depression is intended to be used for treatment of major depressive disorder (MDD) by targeting and delivering non-invasive repetitive TMS stimulation to the patient's dorsolateral prefrontal cortex.

CE mark Indications for use

Nexstim NBS 6 is indicated for MRI-guided and electric field (or E-field) navigated, non-invasive, repetitive TMS stimulation (rTMS) of the motor cortex as therapy to alleviate chronic unilateral neuropathic pain in adult patients. Nexstim NBS 6 is intended to be used by trained clinical professionals. 

SAFETY

NBS 6 THERAPY SHOULD NOT BE GIVEN TO

1. 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.
2. 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.
3. 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.

The most common side effects reported during clinical studies (Lefaucheur et al., Nurmikko et al.) are: mild headache (25% of the TMS treatment group), sleepiness (38 %), and dizziness (15 %).

No severe adverse events were reported. Specifically, no seizures occurred.

In some patients with chronic neuropathic pain, the pain may transiently worsen after rTMS stimulation. The increase in pain sensation may last up to 1-2 days.

No adverse effects on hearing have occurred when ear protection has been properly worn.

No effects on cognitive function has been reported.

Clinical studies have reported no deaths in rTMS therapy. (Nurmikko et al.)