How to Monitor TMS Patients for Adverse Effects
How should clinicians monitor patients receiving transcranial magnetic stimulation for clinically important adverse effects?
Patients receiving TMS may report more than the expected scalp discomfort and headache seen in trials, especially in broader real-world practice. This guide applies to clinicians delivering TMS who need a structured way to watch for distressing, serious, or easily misattributed symptoms during treatment.
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Set expectations before treatment begins
Provide standardized patient education and anticipatory guidance before starting TMS. Counsel patients that real-world adverse-event reports commonly include anxiety, neurocognitive changes, convulsions or seizures, headache, depression, pain, tinnitus, emotional dysregulation, sleep dysfunction, dizziness or vertigo, suicidal ideation, visual disturbances, and hearing-related complaints. Explain that some complaints may be transient or related to the underlying psychiatric illness rather than clearly caused by TMS.
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Screen for seizure vulnerability and protocol risk
Before and during treatment, remain especially alert for seizure risk because seizures were a notable serious signal in the MAUDE reports. The article identifies protocol deviations, proconvulsant medications, and neurologic comorbidities as key risk factors. Adhere closely to treatment protocols and reassess risk if medications or neurologic status change.
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Monitor beyond somatic discomfort after sessions
Do not limit assessment to headache or scalp discomfort alone. The most frequently reported symptom mentions in the MAUDE dataset were anxiety (53, 8.2%), neurocognitive changes (52, 8.0%), convulsions or seizures (45, 6.9%), headache (45, 6.9%), and depression (39, 6.0%), with tinnitus and pain each reported 36 times (5.6%). Ask directly about mood, cognition, auditory symptoms, dizziness, sleep changes, and emotional dysregulation during follow-up.
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Use hearing protection during every session
Ensure patients use well-fitted hearing protection during TMS sessions. The article states coil output can reach up to 120 decibels, exceeding the 85 dB National Institute for Occupational Safety and Health threshold. This is particularly important because tinnitus and hearing-related complaints were reported in the MAUDE data.
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Evaluate neurocognitive complaints in context
If patients report memory loss, cognitive impairment, confusion, or disorientation, monitor these symptoms closely and help distinguish transient treatment-period complaints from illness-related symptoms. The article notes that clinical trials have not shown lasting cognitive deficits with rTMS, so attribution should be cautious. Ongoing assessment and clear counseling can help reduce distress when these symptoms emerge.
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Watch high-risk mood symptoms closely
Monitor suicidal ideation and emotional dysregulation with structured follow-up, especially in patients with severe mood disorders or bipolar risk. The article emphasizes that suicidal ideation reports likely reflect baseline illness severity in many cases and that large reviews do not show elevated mania risk, but careful monitoring remains important in mood disorder populations. Use symptom changes during treatment to clarify whether concerns are worsening, persistent, or consistent with the underlying disorder.
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Consider safety-enhancing device features
When selecting devices, prioritize safety-enhancing features highlighted in the article, including advanced coil architecture, pulse modulation circuitry, and acoustic insulation. The authors note that double-containment coils can reduce acoustic output and that newer pulse-shaping technologies may reduce cortical overstimulation. These features may improve tolerability and reduce stimulation burden.
Clinical Considerations
- MAUDE is a passive surveillance system, so these findings represent qualitative safety signals rather than incidence estimates.
- Event classifications and symptom attribution in MAUDE are reporter-assigned and are not independently verified by the FDA.
- Neurocognitive and psychiatric complaints reported during TMS may reflect nocebo effects or underlying illness rather than direct device causality.
- Manufacturer report counts cannot be normalized to device utilization, so they should not be interpreted as comparative safety rankings.
Bottom Line
TMS monitoring should explicitly track seizures, anxiety, cognitive complaints, and auditory or visual symptoms rather than focusing only on expected headache and scalp discomfort.
