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Can We Deliver TMS to Patients With Implanted Devices? A Practical Summary of the Recent Safety Recommendations

Key Takeaway: The article discusses safety recommendations for delivering Transcranial Magnetic Stimulation (TMS) to patients with implanted devices. It highlights that many misconceptions about TMS and metallic implants are addressed, indicating that TMS is generally safe for such patients. However, it notes that overly conservative FDA guidelines may restrict TMS access, particularly for those with deep brain stimulators.
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Market Sentiment Analysis

POSITIVE FACTORS

  • TMS is deemed safe for patients with various implants.
  • Guidance clarifies misconceptions about TMS and implanted devices.
  • No damage reported to critical implants during TMS procedures.

CONCERNS & RISKS

  • Conservative FDA guidance may limit TMS availability.
  • TMS in patients with deep brain stimulators requires caution.

Full Press Release Details

This article addresses treatment guidance associated with performing TMS on patients with metallic implants, both medical and aesthetic.
The theoretical concerns of conducting TMS with an implanted or non-removable device present are heating of the implanted device if it is made of highly conductive material, mechanical movement of an unanchored implanted device if it is made from a highly ferromagnetic material, demagnetization of implanted permanent magnets, and induction of a current in the wires or electrodes of the implanted device.
Based on the magnetic fields created by TMS coils, the previously published FDA guidance on which manufacturers based their instructions for use documents is likely overly conservative and limits the availability of TMS for patients with implanted devices.
General rules of thumb:
• Anything MRI safe or conditional is TMS safe, including tattoos and jewelry.
• Very conservative guidance is to avoid placing ferromagnetic material within 10 cm of the coil
• Mechanical movement of an implanted device is not a problem
• Heating of non-ferromagnetic material is not a problem
• Even closer than 10 cm, anything anchored such as a screw or plate will not move under the influence of TMS
• Hearing aids should be removed during TMS for hearing protection
• No damage has been seen to implanted vagal and hypoglossal nerve stimulators with TMS
• No damage has been seen to cochlear implants or ventriculoperitoneal shunts with TMS, although manufacturers offer specific MRI guidance
• TMS in patients with deep brain stimulators should be done only if there are justifiable scientific or medical reasons. In such case, the TMS coil should be operated away from the electrode leads
• For patients that have an unknown implant in the skull, it may be useful to use a handheld ferromagnetic detector

Frequently Asked Questions

Is TMS safe for patients with implanted devices?

Yes, TMS is generally safe for patients with various implanted devices.

What are the concerns with TMS and implants?

Concerns include heating of conductive materials and mechanical movement of ferromagnetic devices.

What should be avoided during TMS?

Hearing aids should be removed for hearing protection during TMS.

Can TMS damage vagal nerve stimulators?

No damage has been reported to vagal nerve stimulators during TMS.

What is the guidance for deep brain stimulators?

TMS should be performed cautiously and away from electrode leads.

Last updated: Jul 26, 2023