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Normalization of deviance in neuromodulation for epilepsy.

Karim Mithani^1,2, George M Ibrahim^1,2

¹Division of Neurosurgery, Hospital for Sick Children, Toronto, Ontario, Canada.

|October 13, 2025

Summary

Neuromodulation for epilepsy risks "normalization of deviance," where new practices become standard without proof of safety. Safeguards are needed to balance innovation with patient well-being in neurotherapies.

Keywords:

DRE centromedian deep brain stimulation ethics innovation neuroethics neurotechnologies pulvinar responsive neurostimulation vagus nerve stimultation

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Electroconvulsive Seizures in Rats and Fractionation of Their Hippocampi to Examine Seizure-induced Changes in Postsynaptic Density Proteins

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Area of Science:

Neuroscience
Medical Technology
Patient Safety

Background:

The rise of neuromodulation therapies for drug-resistant epilepsy presents challenges.
Normalization of deviance (NoD) is an emerging risk, where deviations from standard procedures become accepted practice without immediate adverse events.
This phenomenon can inadvertently harm patients despite the goal of improving quality of life.

Purpose of the Study:

To analyze the systemic, institutional, and cultural factors contributing to NoD in epilepsy neuromodulation.
To emphasize the critical balance between advancing neurotechnology innovation and ensuring patient safety.
To propose concrete safeguards against NoD.

Main Methods:

Drawing upon organizational safety research to understand the mechanisms of NoD.
Commentary and analysis of current practices in neuromodulation for epilepsy.
Identification of enabling factors for NoD within the field.

Main Results:

Systemic, institutional, and cultural factors facilitate NoD in neuromodulation for epilepsy.
The pursuit of innovation can create a risk of gradual deviation from safe practices.
Existing safeguards may be insufficient to prevent the normalization of potentially harmful deviations.

Conclusions:

Implementing robust safeguards is crucial to mitigate NoD risks in epilepsy neuromodulation.
Proposed safeguards include enhanced institutional review, centralized data collection, and fostering a safety-first culture.
Prioritizing patient safety alongside technological advancement is essential for the responsible development of neurotherapies.