Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures
NCT ID: NCT05219006
Last Updated: 2023-09-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
17 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-07-15
Study Completion Date
2023-07-02
Brief Summary
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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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Detailed Description
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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.
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.
Conditions
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Non Epileptic Seizures
Functional Neurological Symptom Disorder
Conversion Disorder
Ketogenic Dieting
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
ketogenic dieting
Intervention Type
DIETARY_SUPPLEMENT
Atkins modified diet: 1.2-1.5 g/kg/day of protein with a ratio 1:1 (fat: carbohydrate + protein)
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
Group Type
ACTIVE_COMPARATOR
healthy dieting
Intervention Type
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.
Interventions
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ketogenic dieting
Atkins modified diet: 1.2-1.5 g/kg/day of protein with a ratio 1:1 (fat: carbohydrate + protein)
Intervention Type
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.
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
17 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
OTHER
Sponsor Role
lead
Responsible Party
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Edgar Daniel Crail Melendez
MS
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Edgar Crail Meléndez, MS
Role: PRINCIPAL_INVESTIGATOR
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Locations
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Instituto Nacional de Neurologia Y Neurocirugia Mvs
Mexico City, Mexico City, Mexico
Site Status
Countries
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Mexico
References
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Other Identifiers
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8/21
Identifier Type: -
Identifier Source: org_study_id
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PHASE2
Comparison of the Effectiveness of the Outpatient Classical Ketogenic Diet and Modified Atkins Diet on Seizures Frequency, Nutritional Status and Some Biochemical Factors in Children and Adolescents With Intractable Epilepsy
NCT03014752
COMPLETED
PHASE2/PHASE3
The Role of Gut Microbiota in Children With Epilepsy Following Ketogenic Diet
NCT05898438
UNKNOWN
Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug
NCT00043901
COMPLETED
PHASE4
Internet Administration of the Modified Atkins Diet for Adults With Intractable Epilepsy
NCT00436631
COMPLETED
PHASE3
Efficacy of Modified Ketogenic Diet (Atkins) in Management of Epilepsy
NCT00188500
UNKNOWN
NA
Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy
NCT02660255
APPROVED_FOR_MARKETING
Efficacy of Low Glycemic Index Diet Versus Classic Ketogenic Diet in Pediatric Epilepsy Treatment
NCT06703983
COMPLETED
NA
A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults
NCT02224690
COMPLETED
PHASE3
Microbiome Composition and Biomarker Discovery in Refractory Pediatric Epilepsy
NCT04311242
WITHDRAWN
Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
NCT01118962
COMPLETED
PHASE2
Efficacy of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy
NCT01899898
COMPLETED
PHASE2/PHASE3
A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures
NCT00297349
COMPLETED
Pharmacokinetics Study of Oral 2-Deoxy-D-Glucose (2DG) in Subjects With a Confirmed Diagnosis of Epilepsy
NCT05605301
COMPLETED
PHASE2
A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
NCT00425282
COMPLETED
PHASE3
An Open-Label Extension Study to Evaluate the Safety and Effectiveness of RWJ 333369 in Patients With Epilepsy
NCT00210652
COMPLETED
PHASE2
Evaluation and Treatment of Patients With Epilepsy
NCT00013845
TERMINATED
The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients
NCT03403907
COMPLETED
NA