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Completed

NCT Number: NCT05219006

Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures

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.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Neurologia Y Neurocirugia Mvs

Mexico City, 14269, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketogenic dieting

Dietary Supplement

Atkins modified diet: 1.2-1.5 g/kg/day of protein with a ratio 1:1 (fat: carbohydrate + protein)

healthy dieting

Dietary Supplement

Normocaloric diet established by a nutritionist. 1.2-1.5 g/kg/day of protein with a maximum contribution of 50 % carbohydrates of the total calorie intake eliminating industrialized food.

Primary outcomes

  1. non epileptic seizure frequency

    Time frame: 2 weeks

    number of non epileptic seizures the patient reports on a written crisis record with the aid of a caregiver if necessary

Sponsors and collaborators

Lead sponsor

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Other

Registry information

Official study title

Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures in Patients With Dissociative Neurological Symptom Disorder: a Pilot Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2022
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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