Deep brain stimulation of the thalamus for intractable epilepsy (FRANCE study): A randomized clinical trial
Abstract
Objective: This study was undertaken to evaluate the efficacy and safety of deep brain stimulation (DBS) of the anterior nucleus of the thalamus (ANT) compared with best medical treatment (BMT) in patients with drug-resistant epilepsy (DRE).Methods: This randomized, open-label, phase 3 controlled trial was conducted across 14 specialized epilepsy and DBS centers. Eligible participants were adults with focal or multifocal DRE who had previously failed vagus nerve stimulation (VNS). Sixty-one patients were randomized 1:1 either to receive continuous bilateral ANT-DBS (n = 30) or to continue BMT, including VNS (n = 31), for 12 months. Afterward, patients in the BMT group were offered delayed ANT-DBS and followed for an additional year. The primary outcome was the change in monthly severe seizure frequency (defined on the modified Chalfont Scale) at 12 months. Safety outcomes were also recorded.Results: Among 67 screened patients, 61 were enrolled. At 12 months, median seizure reduction was greater in the DBS group (-44%, interquartile range [IQR] = -67 to 0) versus the BMT group (-6%, IQR = -56 to 20; p = .09); 44.5% of patients in the DBS group achieved a ≥50% reduction in seizure frequency compared to 27% in the BMT group. Within-group analyses showed significant seizure reductions in the DBS group at both 12 months (-44%, p < .001) and 24 months (-46%, p < .001), as well as in the delayed DBS group at 12 months (-36%, IQR = -73 to -4; p < .001). No significant differences in quality of life were observed between groups, and no major DBS-related adverse events were reported.Significance: Our study suggests a potential benefit rather than demonstrating superiority of ANT-DBS over medical therapy. However, within-group improvements and favorable safety profile support the use of ANT-DBS as a palliative treatment option in patients with DRE who have failed VNS.
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BibTeX
@article{chabardes2026deep,
title = {{Deep brain stimulation of the thalamus for intractable epilepsy (FRANCE study): A randomized clinical trial}},
author = {Stephan Chabardes and Fabrice Bartolomei and Anca Nica and Claire Haegelen and Lorella Minotti and Brigitte Piallat and Chrystèle Mosca and Sandrine Massicot and Sylvain Rheims and Marc Guenot and Pr. Emmanuel Cuny and Jérôme Aupy and Louis Maillard and Sophie Colnat-Coulbois and Corentin Leroy and Romain Carron and Philippe Coubes and Philippe Gélisse and Carine Karachi and Vincent Navarro and Bertrand Devaux and Francine Chassoux and Phlippe Derambure and Nicolas Reyns and Jean Christope Sol and Luc Valton and Denys Fontaine and Veronique Bourg and Philippe Kahane and Sandra David-Tchouda and Jean Régis},
journal = {Epilepsia},
year = {2026},
month = oct,
doi = {10.1002/epi.70211},
url = {https://hal.science/hal-05574571v1},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - Deep brain stimulation of the thalamus for intractable epilepsy (FRANCE study): A randomized clinical trial
AU - Stephan Chabardes
AU - Fabrice Bartolomei
AU - Anca Nica
AU - Claire Haegelen
AU - Lorella Minotti
AU - Brigitte Piallat
AU - Chrystèle Mosca
AU - Sandrine Massicot
AU - Sylvain Rheims
AU - Marc Guenot
AU - Pr. Emmanuel Cuny
AU - Jérôme Aupy
AU - Louis Maillard
AU - Sophie Colnat-Coulbois
AU - Corentin Leroy
AU - Romain Carron
AU - Philippe Coubes
AU - Philippe Gélisse
AU - Carine Karachi
AU - Vincent Navarro
AU - Bertrand Devaux
AU - Francine Chassoux
AU - Phlippe Derambure
AU - Nicolas Reyns
AU - Jean Christope Sol
AU - Luc Valton
AU - Denys Fontaine
AU - Veronique Bourg
AU - Philippe Kahane
AU - Sandra David-Tchouda
AU - Jean Régis
PY - 2026
DA - 2026/10/13
JO - Epilepsia
DO - 10.1002/epi.70211
UR - https://hal.science/hal-05574571v1
AB - Objective: This study was undertaken to evaluate the efficacy and safety of deep brain stimulation (DBS) of the anterior nucleus of the thalamus (ANT) compared with best medical treatment (BMT) in patients with drug-resistant epilepsy (DRE).Methods: This randomized, open-label, phase 3 controlled trial was conducted across 14 specialized epilepsy and DBS centers. Eligible participants were adults with focal or multifocal DRE who had previously failed vagus nerve stimulation (VNS). Sixty-one patients were randomized 1:1 either to receive continuous bilateral ANT-DBS (n = 30) or to continue BMT, including VNS (n = 31), for 12 months. Afterward, patients in the BMT group were offered delayed ANT-DBS and followed for an additional year. The primary outcome was the change in monthly severe seizure frequency (defined on the modified Chalfont Scale) at 12 months. Safety outcomes were also recorded.Results: Among 67 screened patients, 61 were enrolled. At 12 months, median seizure reduction was greater in the DBS group (-44%, interquartile range [IQR] = -67 to 0) versus the BMT group (-6%, IQR = -56 to 20; p = .09); 44.5% of patients in the DBS group achieved a ≥50% reduction in seizure frequency compared to 27% in the BMT group. Within-group analyses showed significant seizure reductions in the DBS group at both 12 months (-44%, p < .001) and 24 months (-46%, p < .001), as well as in the delayed DBS group at 12 months (-36%, IQR = -73 to -4; p < .001). No significant differences in quality of life were observed between groups, and no major DBS-related adverse events were reported.Significance: Our study suggests a potential benefit rather than demonstrating superiority of ANT-DBS over medical therapy. However, within-group improvements and favorable safety profile support the use of ANT-DBS as a palliative treatment option in patients with DRE who have failed VNS.
SN - 0013-9580
SN - 1528-1167
ER -