The Keto-eCoach program: A randomised controlled trial of a multimodality digital health intervention to aid the delivery of ketogenic diet therapy for epilepsy.

Alfred Health0 个研究点目标入组 136 人开始时间: 2024年4月19日最近更新: 2024年4月29日

适应症

试验速览

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•1. Male or female, aged 18 years and over, and less than 60 years.
•2.Diagnosis of drug-resistant epilepsy according to ILAE definition, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom”.
•3.Must be under the care of a neurologist for their epilepsy treatment.
•4.Experiencing 2 or more seizures per 28-days during the 4-week baseline screening phase.
•5.Not currently on ketogenic diet therapy.
•6.No changes made to concomitant anti-seizure medications, or neuromodulation settings in the prior four weeks to enrolment.
•7.Access to a smartphone, tablet and/or computer and internet access.
•8.Has a Medicare card.
•9.Is living in Australia.
•10.Proficient in speaking and reading English.

•1. Contraindications to the modified ketogenic diet for epilepsy, including fatty acid and/or amino acid oxidation or transport disorders.
•2. Current or previous diagnosis of an eating disorder
•3. Pregnancy or breast-feeding
•4. Diagnosis of diabetes mellitus, serious hepatic or renal disease, or cancer.
•5. Current substance abuse disorder that may affect treatment adherence or response
•6. Psychogenic non-epileptic (functional) seizures within the past 12 months.
•7. Elevated fasting serum total cholesterol, LDL cholesterol and/or triglyceride levels at baseline, defined as >10% above the reference range. Participants will be excluded if baseline serum total cholesterol is >6.1mmol/L, LDL cholesterol is >2.2mmol/L and/or triglycerides is >2.2mmol/L.

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