Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures

Ketogenic Dieting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05219006
• Other study ID #: 8/21
• Status: Completed
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: July 2, 2023

Study information

• Verified date: September 2023
• Source: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Conversion Disorder
• Dissociative Disorders
• Functional Neurological Symptom Disorder
• Ketogenic Dieting
• Seizures

Intervention

Dietary Supplement:
• ketogenic dieting
Atkins modified diet: 1.2-1.5 g/kg/day of protein with a ratio 1:1 (fat: carbohydrate + protein)
• healthy dieting
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.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Neurologia Y Neurocirugia Mvs	Mexico	Ciudad De Mexico

Sponsors (1)

Lead Sponsor	Collaborator
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Country where clinical trial is conducted

Mexico, 

References & Publications (65)

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* Note: There are 65 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	non epileptic seizure frequency	number of non epileptic seizures the patient reports on a written crisis record with the aid of a caregiver if necessary	2 weeks