Details

Autor(en) / Beteiligte

• KLINKENBERG, SYLVIA
• AALBERS, MARLIEN W
• VLES, JOHAN S H
• CORNIPS, ERWIN M J
• RIJKERS, KIM
• LEENEN, LOES
• KESSELS, FONS G H
• ALDENKAMP, ALBERT P
• MAJOIE, MARIAN

Titel

Vagus nerve stimulation in children with intractable epilepsy: a randomized controlled trial

Ist Teil von

• Developmental medicine and child neurology, 2012-09, Vol.54 (9), p.855-861

Ort / Verlag

Oxford, UK: Blackwell Publishing Ltd

Erscheinungsjahr

2012

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• Aim  The aim of this study was to evaluate the effects of vagus nerve stimulation (VNS) in children with intractable epilepsy on seizure frequency and severity and in terms of tolerability and safety. Method  In this study, the first randomized active controlled trial of its kind in children, 41 children (23 males; 18 females; mean age at implantation 11y 2mo, SD 4y 2mo, range 3y 10mo–17y 8mo) were included. Thirty‐five participants had localization‐related epilepsy (25 symptomatic; 10 cryptogenic), while six participants had generalized epilepsy (four symptomatic; two idiopathic). During a baseline period of 12 weeks, seizure frequency and severity were recorded using seizure diaries and the adapted Chalfont Seizure Severity Scale (NHS3), after which the participants entered a blinded active controlled phase of 20 weeks. During this phase, half of the participants received high‐output VNS (maximally 1.75mA) and the other half received low‐output stimulation (0.25mA). Finally, all participants received high‐output stimulation for 19 weeks. For both phases, seizure frequency and severity were assessed as during the baseline period. Overall satisfaction and adverse events were assessed by semi‐structured interviews. Results  At the end of the randomized controlled blinded phase, seizure frequency reduction of 50% or more occurred in 16% of the high‐output stimulation group and in 21% of the low‐output stimulation group (p=1.00). There was no significant difference in the decrease in seizure severity between participants in the stimulation groups. Overall, VNS reduced seizure frequency by 50% or more in 26% of participants at the end of the add‐on phase The overall seizure severity also improved (p<0.001). Interpretation  VNS is a safe and well‐tolerated adjunctive treatment of epilepsy in children. Our results suggest that the effect of VNS on seizure frequency in children is limited. However, the possible reduction in seizure severity and improvement in well‐being makes this treatment worth considering in individual children with intractable epilepsy. This article is commented on by Pressler on page 782‐783 of this issue.