Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Status: Completed

Conditions: Functional Neurological Symptom Disorder; Ketogenic Dieting; Conversion Disorder; Non Epileptic Seizures

Treatments: Dietary Supplement: healthy dieting; Dietary Supplement: ketogenic dieting

Study type: Interventional

Funder types: Other

Identifiers

NCT05219006

8/21

Details and patient eligibility

About

The objective of this study is to determine the effects of the ketogenic diet on the frequency of non-epileptic seizures in patients with functional neurological symptoms disorder compared to a healthy diet.

Full description

This study consists of a open label randomized controlled clinical trial comprised of 20 patients with diagnosis of functional neurological symptom disorder with non epileptic seizures distributed in 2 arms of 10 patients each.

Patients will be randomly assigned to one of the groups. Both groups will be receiving treatment as usual (SSRI and/or psychotherapy). One group will be assigned a ketogenic diet while the other will be assigned a healthy diet, both supervised by a team of nutritionists. Patients will be evaluated every 2 weeks until reaching 6 weeks.

Enrollment: 17 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have a record at the institute and who have a diagnosis of a dissociative neurological symptom disorder with non-epileptic seizures with a certainty of at least clinically established who have a monthly seizure frequency greater than 3.
• Patients with the characteristics described above with comorbid epilepsy but who have not presented epileptic seizures in the last month.
• Patients with the aforementioned characteristics and who give their informed consent in writing to participate in the study.
• Patients who, once the diet has been explained to them, consider it feasible to implement it at least for the follow-up time.

Exclusion criteria

• Patients with metabolic or hemodynamic instability, liver failure, inability to tolerate the oral route, acute pancreatitis or pregnancy due to the possible teratogenic effect that has not yet been elucidated.
• Patients with metabolic disorders such as primary carnitine deficiency, palmitoyltransferase carnitine I or II deficiency, carnitine translocase deficiency, beta oxidation defects, pyruvate carboxylase deficiency, porphyria and other fatty acid transport and oxidation disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

ketogenic dieting + conventional treatment

Experimental group

Description:

Nutrition team will help patients implement an Atkins-type ketogenic diet. The diet should be continued for at least 6 weeks. They will be able to continue with the pharmacological-based treatment but without any changes having been made in the last 6 weeks or during the time they are in the study. To ensure adherence to the diet, urine ketones will be determined twice a week.

Treatment:

Dietary Supplement: ketogenic dieting

Healthy dieting + conventional treatment

Active Comparator group

Description:

In addition to their basic (pharmacological) treatment, the nutrition team will help them implement a low-calorie, non-ketogenic diet. The presence of ketones will also be determined in urine to avoid bias

Treatment:

Dietary Supplement: healthy dieting