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FDA-Approved ADHD Device Fails to Outperform Placebo

1/20/2026

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Summary

Story summary

A Nature Medicine trial found that external trigeminal nerve stimulation (TNS), an FDA-approved device for treating ADHD in children, is ineffective.
The 150-participant study showed no significant difference in symptom reduction between TNS and placebo.
Both groups improved similarly, driven by strong placebo effects.
FDA cleared the device in 2019 based on a smaller trial, but researchers say better controls are needed to avoid misleading results.

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Story summary

A Nature Medicine trial found that external trigeminal nerve stimulation (TNS), an FDA-approved device for treating ADHD in children, is ineffective.
The 150-participant study showed no significant difference in symptom reduction between TNS and placebo.
Both groups improved similarly, driven by strong placebo effects.
FDA cleared the device in 2019 based on a smaller trial, but researchers say better controls are needed to avoid misleading results.