INDICATIONS FOR USE

FDA: 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. Nexstim NBT System 2 is intended to be used by trained clinical professionals.

NBT 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.