Safety Considerations for the Use of Transcranial Magnetic Stimulation as Treatment for Coma Recovery in People With Severe Traumatic Brain Injury.
Sandra L Kletzel, Alexandra L Aaronson, Ann Guernon and 10 others
PMID 33165155WHAT IT FOUND
In seven patients with severe traumatic brain injury and disorders of consciousness, transcranial magnetic stimulation was generally safe.
One seizure occurred during treatment but was atypical. The authors conclude the protocol is relatively safe for medically stable patients with widespread neuropathology but no large lesions near the stimulation site.
Key findings
01Across the two studies, one serious adverse event (a seizure) occurred during the open-label trial, while the baseline-controlled trial reported no serious adverse events during the intervention phase.
02The seizure that occurred was detected only by EEG, happened 40 minutes after treatment, and arose in a non-stimulated hemisphere, leading the authors to question whether it was caused by the stimulation.
03Patients with programmable ventriculoperitoneal shunts required valve pressure resetting after every stimulation session and magnetic resonance scan, but no shunt malfunctions or hydrocephalus symptoms occurred.
STILL TO COME
How it was doneWhat they foundWhat it means for SLPs
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What it does not show
The sample size is extremely small (seven patients), limiting the generalizability of safety findings. The study was not designed to test efficacy, only safety, so it provides no evidence that the treatment improves consciousness or communication. One serious adverse event (seizure) had atypical features, making the causal link to the treatment uncertain. Post-study seizure reports were unconfirmed by EEG in one case and occurred weeks after treatment, complicating the interpretation of long-term risk. The population was highly selected (medically stable, no large lesions near stimulation site), so safety findings may not apply to more complex or unstable patients.
Declared interests
The authors declare no conflicts of interest.
The easy way to misread this
Do not interpret this paper as evidence that transcranial magnetic stimulation improves outcomes for patients with disorders of consciousness. This is a safety report from a very small sample (n=7) that explicitly states the findings should not be interpreted as advocating for any less rigorous monitoring of safety. The efficacy of this treatment for coma recovery is not established here.