Deep brain stimulation of the thalamus for intractable epilepsy (FRANCE study): A randomized clinical trial - PubMed

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The FRANCE study, a phase 3 randomized controlled trial, investigated deep brain stimulation (DBS) of the anterior nucleus of the thalamus (ANT) versus best medical treatment (BMT) for adults with drug-resistant epilepsy who previously failed vagus nerve stimulation.
At 12 months, median seizure reduction was -44% in the DBS group versus -6% in the BMT group, with 44.5% of DBS patients achieving ≥50% reduction compared to 27% in the BMT group, although the between-group difference was not statistically significant (p = .09).
Within-group analyses showed significant seizure reductions in the DBS group at 12 months (-44%) and 24 months (-46%), and in the delayed DBS group at 12 months (-36%). No significant quality-of-life differences were found, and the treatment had a favorable safety profile with no major DBS-related adverse events reported.
The study suggests a potential benefit of ANT-DBS as a palliative treatment option for drug-resistant epilepsy patients who have failed vagus nerve stimulation, rather than demonstrating clear superiority over medical therapy, based on within-group improvements and safety.

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