Efficacy and Tolerability of Ketogenic Diet As Addon Therapy In Children With Eses

Background : There is scarce data on management of electrical status epilepticus in sleep (ESES) refractory to antiseizure medications (ASM) and corticosteroids. We explored efficacy and tolerability of ketogenic diet (KD) as an add-on therapy. Methods: A non-randomized single-arm interventional study was conducted in children aged 2-16 years, with ESES refractory to two ASM and corticosteroids. Primary outcome was change in spike-wave index (SWI) at 12 weeks. Secondary outcomes were change in seizure frequency at 4,12, and 24 weeks; SWI change at 24 weeks, and neuropsychological outcomes (change in behavior, language, SQ) at 24 weeks. Results: Twenty-two patients were analyzed as per the modified-intention-to-treat-protocol. KD was continued upto 12 weeks by 45% patients(n=10) and upto 24 weeks by 31%(n=7). Seizure reduction was seen in 82%, 90%, and 100% patients at 4,12 and 24 weeks respectively. However, there was no statistically significant change in mean SWI (p=0.3) at 12 and 24 weeks. Amongst neuropsychological outcomes, 40% children improved behavior and 60% improved in language . There was no significant change in mean SQ before and after KD (p=>0.05). One patient (4.5%) developed grade III adverse effect (hypoglycemia) while 54% (n=11) developed grade I/II adverse effects.

Conclusions: KD is effective in reducing seizure burden at 4, 12 and 24 weeks . KD caused improvement in SWI at 12 weeks however the change was not statistically significant. KD led to subjective improvement in behavior and language at 24 weeks. Our study showed that KD is effective and tolerable in children with ESES. (CTRI/2022/07/043923)