Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures

September 26, 2023 updated by: Edgar Daniel Crail Melendez, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Ciudad De Mexico
      • Mexico, Ciudad De Mexico, Mexico, 14269
        • Instituto Nacional de Neurologia Y Neurocirugia Mvs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ketogenic dieting + conventional treatment
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
Atkins modified diet: 1.2-1.5 g/kg/day of protein with a ratio 1:1 (fat: carbohydrate + protein)
Active Comparator: Healthy dieting + conventional treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Investigators

  • Principal Investigator: Edgar Crail Meléndez, MS, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2021

Primary Completion (Actual)

May 20, 2023

Study Completion (Actual)

July 2, 2023

Study Registration Dates

First Submitted

January 20, 2022

First Submitted That Met QC Criteria

January 20, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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