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AI-Guided Home Neurostimulator Gains CE Approval, Targets Pilot Programs

Gaining CE approval, the AI-driven headset will now enter pilot deployment in educational, training, clinical settings following peer-reviewed trials that showed safety plus focus gains.

Those who received personalised AI-guided stimulation showed significantly better performance than during standard or placebo stimulation. Credit: Neuroscience News
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Conceptual AI-generated image unaffiliated with the study depicting a woman wearing a brain stimulation headset. (© NEW KUNG - stock.adobe.com)

Overview

  • The CE-marked wearable uses AI-driven Bayesian algorithms to personalize transcranial random noise stimulation parameters based on head anatomy and baseline attention without MRI.
  • Peer-reviewed validation in npj Digital Medicine confirmed significant gains in sustained attention for participants receiving AI-tailored stimulation versus placebo or standard protocols.
  • Home-based deployment over 290 sessions with 103 participants and a double-blind study of 37 volunteers reported no serious side effects or increased discomfort.
  • Individuals with lower baseline focus experienced the largest improvements, indicating targeted benefits for users with attention deficits.
  • Following CE approval, pilot programs are planned in educational, training, clinical environments while longer-term and broader population studies remain under consideration.