Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures

Not Applicable

Completed

• Conditions: Conversion Disorder; Ketogenic Dieting; Functional Neurological Symptom Disorder; Non Epileptic Seizures
• Interventions: Dietary Supplement: ketogenic dieting; Dietary Supplement: healthy dieting

• Registration Number: NCT05219006
• Lead Sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-07-15
• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-01
• Primary Completion: 2023-05-20
• Study Completion: 2023-07-02
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketogenic dieting + conventional treatment	ketogenic dieting	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.
Healthy dieting + conventional treatment	healthy dieting	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

Primary Outcome Measures

Name	Time	Method
non epileptic seizure frequency	2 weeks	number of non epileptic seizures the patient reports on a written crisis record with the aid of a caregiver if necessary

Trial Locations

Locations (1)

Instituto Nacional de Neurologia Y Neurocirugia Mvs; 🇲🇽 Mexico, Ciudad De Mexico, Mexico