Indications for use (CE mark) and patient safety
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
- 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.
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.)
*Lefaucheur JP et al. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-206. https://www.ncbi.nlm.nih.gov/pubmed/25034472
Nurmikko T et al. Motor Cortex Reorganization and Repetitive Transcranial Magnetic Stimulation for Pain-A Methodological Study. Neuromodulation. 2016 Oct;19(7):669-678. https://www.ncbi.nlm.nih.gov/pubmed/27187056
Other
Ahdab R, Lefaucheur JP 2nd International Symposium on Navigated Brain Stimulation in Neurosurgery Charité - Universitätsmedizin Berlin (Organizer) 2011 May; 34-36
Mylius V, Lefaucheur JP 3rd International Symposium on Navigated Brain Stimulation in Neurosurgery Charité - Universitätsmedizin Berlin (Organizer) 2012 May; 27-29
Nurmikko TJ, Sacco P 3rd International Symposium on Navigated Brain Stimulation in Neurosurgery Charité - Universitätsmedizin Berlin (Organizer) 2012 May; 23-26
Nurmikko TJ, Sacco P 5th International Symposium on Navigated Brain Stimulation in Neurosurgery Charité - Universitätsmedizin Berlin (Organizer) 2014 June; 32-36
Nurmikko T et al. Motor Cortex Reorganization and Repetitive Transcranial Magnetic Stimulation for Pain-A Methodological Study. Neuromodulation. 2016 Oct;19(7):669-678.