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Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures

Primary Purpose

Non Epileptic Seizures, Functional Neurological Symptom Disorder, Conversion Disorder

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
ketogenic dieting
healthy dieting
Sponsored by
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Epileptic Seizures

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto Nacional de Neurologia Y Neurocirugia Mvs

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ketogenic dieting + conventional treatment

Healthy dieting + conventional treatment

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 20, 2022
Last Updated
September 26, 2023
Sponsor
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
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1. Study Identification

Unique Protocol Identification Number
NCT05219006
Brief Title
Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures
Official Title
Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures in Patients With Dissociative Neurological Symptom Disorder: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
May 20, 2023 (Actual)
Study Completion Date
July 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Epileptic Seizures, Functional Neurological Symptom Disorder, Conversion Disorder, Ketogenic Dieting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ketogenic dieting + conventional treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy dieting + conventional treatment
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
ketogenic dieting
Intervention Description
Atkins modified diet: 1.2-1.5 g/kg/day of protein with a ratio 1:1 (fat: carbohydrate + protein)
Intervention Type
Dietary Supplement
Intervention Name(s)
healthy dieting
Intervention Description
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 Outcome Measure Information:
Title
non epileptic seizure frequency
Description
number of non epileptic seizures the patient reports on a written crisis record with the aid of a caregiver if necessary
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar Crail Meléndez, MS
Organizational Affiliation
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Neurologia Y Neurocirugia Mvs
City
Mexico
State/Province
Ciudad De Mexico
ZIP/Postal Code
14269
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
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Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures

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