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.
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.
- Depressed mood most of the day as indicated by either subjective report or observation made by others
- Markedly diminished interest or pleasure in all, or almost all, activities most of the day
- Significant weight loss or weight gain, or decrease or increase in appetite
- Insomnia or hypersomnia
- Psychomotor agitation or retardation
- Fatigue or loss of energy
- Feelings of worthlessness or excessive or inappropriate guilt
- Diminished ability to think or concentrate, or indecisiveness
- Recurrent thoughts of death, recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide.
Efficacy of the treatment was established in retrospective analysis (see Lisanby et al.**) for the outpatient group (164 patients, aged 18-70 years) who had one adequate antidepressant treatment in the current episode but failed to achieve satisfactory improvement and were moderately to severely symptomatic. Efficacy of treatment, sham or active stimulation, was measured in total change in MADRS score at 2, 4 and 6 weeks into treatment when compared to baseline level (see the figure).
*O’Reardon et al., Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry 2007 Dec 1; 62(11): 1208-1216. Epub 2007 Jun 14. PubMed PMID: 17573044.
**Lisanby et al., Daily left prefrontal repetitive transcranial magnetic stimulation in the acute treatment of major depression: clinical predictors of outcome in a multisite, randomized controlled clinical trial. Neuropsychopharmacology. 2009 Jan; 34(2):522-34. Epub 2008 Aug 13. PubMed PMID: 18704101.
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