Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures

NCT05219006 | Completed

• 1 other identifier: 8/21
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ketogenic dieting + conventional treatment

EXPERIMENTAL

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.

Dietary Supplement: ketogenic dieting

Healthy dieting + conventional treatment

ACTIVE COMPARATOR

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

Dietary Supplement: healthy dieting

Interventions

ketogenic dieting DIETARY_SUPPLEMENT

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

ketogenic dieting + conventional treatment

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.

Healthy dieting + conventional treatment

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez: lead

Study Sites (1)

Instituto Nacional de Neurologia Y Neurocirugia Mvs

Mexico City, Mexico City, 14269, Mexico

Location

Related Publications (65)

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MeSH Terms

Conditions

Seizures; Conversion Disorder

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatoform Disorders; Mental Disorders

Study Officials

• Edgar Crail Meléndez, MS

  El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MS

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 1, 2022
• Study Start: July 15, 2021
• Primary Completion: May 20, 2023
• Study Completion: July 2, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)