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FDA Okays MRI with Epilepsy Brain Stimulation

Brain activity graphic

(Gordon Johnson, Pixabay)

9 Mar. 2020. A company making brain stimulation systems to treat epilepsy received regulatory clearance for MRI scans in people with its implanted devices. NeuroPace Inc. in Mountain View, California says it received authorization from the U.S. Food and Drug Administration for people with the company’s implanted RNS-320 system to have full-body MRI scans under specified conditions.

The company makes implanted devices that treat epilepsy with localized and personalized brain stimulation. Epilepsy is a neurological disorder where nerve cell activity in the brain is disturbed, causing seizures with symptoms ranging from blank stares to tingling sensations to loss of consciousness. World Health Organization estimates some 50 million people worldwide have epilepsy, where in many cultures people with the condition face stigma and discrimination.

NeuroPace makes Responsive Neurostimulator System or RNS devices, surgically implanted in the brains of people whose epilepsy does not respond to drug therapies. The RNS device detects impending signals of a seizure, then sends electronic impulses to two areas of the brain associated with the onset of seizures. Patients can also start the device manually when they sense the onset of a seizure. The system records brain activity during these sessions, with the data downloaded to an external system, such as a doctor’s laptop, for further analysis.

FDA’s authorization, says NeuroPace, allows people with an implanted RNS system and facing other brain disorders, such as brain tumor or multiple sclerosis, or health conditions requiring an MRI to receive a full-body scan. In January, Science & Enterprise reported on the ability of NeuroPace devices to detect multiple neurological conditions in people with epilepsy. Researchers found one in four individuals in a sample of people with epilepsy using a NeuroPace system showed symptoms of other neuro-psychiatric conditions, such as panic attacks and psychosis.

Magnetic resonance imaging is a non-invasive diagnostic technique that sends magnetic waves through the body. Those waves bounce off tissue in various characteristic ways, enabling radiologists to get detailed pictures of internal organs. Magnetic fields are safe for brain and spinal cord cells, and can highlight connective tissue injuries, such as muscles and tendons, better than X-rays. However, the waves can also interrupt some electronic devices such as brain implants.

The company says its RNS-320 system is rated safe for MRI scans with 1.5T — for Tesla, a measure of magnet strength —  under certain conditions, but not its RNS-300 system. The RNS-320 has an MRI mode that must be switched on first by a clinician before the scan, then switched off after the scan. NeuroPace also prepared a checklist for radiologists conducting the scan. External components of RNS systems, such as remote monitor and wand, are rated unsafe for MRI, and the company instructs patients not to bring them to an MRI scan.

“MRI conditional labeling,” says Michael Favet, president of NeuroPace in a company statement released through BusinessWire, “opens up valuable medical imaging possibilities for our patients treated with the model RNS-320 neurostimulator, who can now receive full-body 1.5T magnetic resonance imaging scans under appropriate conditions.”

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