Evidence map›Paper›PMID 41902639›Full record

Trial reportEpilepsia2026

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

Stéphan Chabardès, Fabrice Bartolomei, Anca Nica, Claire Haegelen, Lorella Minotti, Brigitte Piallat, Chrystele Mosca, Sandrine Massicot, Sylvain Rheims, Marc Guenot and 21 more

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Epilepsia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors.

Stéphan ChabardèsNeurosurgery Department, Grenoble Alpes University, Grenoble Alpes University Hospital, Grenoble, France.ORCID https://orcid.org/0000-0002-7930-1476
Fabrice BartolomeiAsssistance Publique Hopitaux de Marseille, Epileptology and Cerebral Rhythmology, Timone Hospital, Marseille, France.ORCID https://orcid.org/0000-0002-1678-0297
Anca NicaUniversity of Rennes, Inserm, LTSI-U1099, Rennes, France.
Claire HaegelenUniversity of Rennes, Inserm, LTSI-U1099, Rennes, France.ORCID https://orcid.org/0000-0002-8341-4887
Lorella MinottiNeurology Department, Grenoble Alpes University, Grenoble Alpes University Hospital, Grenoble, France.
Brigitte PiallatGrenoble Alpes University, Inserm, U1216, Grenoble Institut Neurosciences, Grenoble, France.ORCID https://orcid.org/0000-0001-9660-4850
Chrystele MoscaNeurology Department, Grenoble Alpes University, Grenoble Alpes University Hospital, Grenoble, France.
Sandrine MassicotGrenoble Alpes University, Inserm, CNRS, Grenoble INP, TIMC, Grenoble, France.
Sylvain RheimsDepartment of Functional Neurology and Epileptology, Hospices Civils de Lyon and Lyon 1 University, Bron, France.
Marc GuenotDepartment of Functional Neurosurgery, Hospices Civils de Lyon, Pierre Wertheimer Neurological Hospital, Bron, France.
Emmanuel CunyNeurochirurgie B. CHU de Bordeaux, Bordeaux, France.
Jérome AupyDepartment of Neurology, Section of Epileptology, Bordeaux University Hospital Center, Bordeaux, France.ORCID https://orcid.org/0000-0001-7268-7479
Louis MaillardService de Neurologie, Centre de Référence des Épilepsies Rares, CHRU de Nancy; CNRS, IMoPA, Université de Lorraine, Nancy, France.
Sophie Colnat-CoulboisService de Neurochirurgie, Université de Lorraine, CHRU, Nancy, France.
Corentin LeroyData Engineering Unit, CIC, Public Health Department, Grenoble Alpes University, Inserm, Grenoble Alpes University Hospital, Grenoble, France.
Romain CarronAsssistance Publique Hopitaux de Marseille, Epileptology and Cerebral Rhythmology, Timone Hospital, Marseille, France.
Philippe CoubesEpilepsy Monitoring and Surgery Unit, Département de Neurochirurgie, Unité "Pathologies Cérébrales Résistantes", Centre Hospitalo-Universitaire Gui de Chauliac, Montpellier, France.
Philippe GélisseEpilepsy Unit, Gui de Chauliac Hospital, Montpellier, France.ORCID https://orcid.org/0000-0001-9296-1957
Carine KarachiBrain Institute-ICM & Neurosurgery Department, Hôpital Pitié-Salpêtrière, AP-HP, Sorbonne Université, Paris, France.
Vincent NavarroBrain Institute-ICM, ICM, Inserm, CNRS, AP-HP, Epilepsy Unit and Center of Reference for Rare Epilepsies, European Reference Network EpiCARE, Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France.ORCID https://orcid.org/0000-0003-0077-8114
Bertrand DevauxService de Neurochirurgie, AP-HP, Hôpital Lariboisière, Paris, France.
Francine ChassouxService de Neurochirurgie, AP-HP, Hôpital Lariboisière, Paris, France.
Phlippe DerambureDepartment of Clinical Neurophysiology, Lille University Hospital, Lille, France.
Nicolas ReynsNeurosurgery Department, University of Lille, CHU Lille, Lille, France.
Jean Christope SolToulouse University Hospital, Toulouse, France.
Luc ValtonDepartment of Neurology, Toulouse University Hospital, Brain and Cognition Research Center, Centre National de la Recherche Scientifique, UMR5549, Toulouse, France.
Denys FontaineDepartment of Neurosurgery, Côte d'Azur University, Nice, France.
Veronique BourgDepartment of Neurology, Côte d'Azur University, Nice, France.
Philippe KahaneGrenoble Alpes University, Inserm, U1216, Grenoble Institut Neurosciences, Grenoble, France.
Sandra David-TchoudaNeurology Department, Grenoble Alpes University, Grenoble Alpes University Hospital, Grenoble, France.
Jean RegisDepartment of Functional Neurosurgery & Radiosurgery, Inserm UMR1106, Aix Marseille University, Marseille, France.

Funding

Direction Générale de l'offre de Soins
6 · The paper itself

Abstract

objectiveThis 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).

methodsThis 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.

resultsAmong 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.

Indexed as

Anterior Thalamic NucleiDeep Brain StimulationDrug Resistant EpilepsyThalamusAdolescentAdultAnticonvulsantsFemaleFranceHumansMaleMiddle AgedTreatment OutcomeVagus Nerve StimulationYoung AdultAnticonvulsantsanterior nucleus of the thalamusdeep brain stimulationdrug‐resistant epilepsyvagus nerve stimulation

Identifiers

PMID41902639
PMCPMC13360963

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.