Clinical trial NCT05219006: 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
Overall status: COMPLETED
Phase: NA
Conditions: Non Epileptic Seizures
Functional Neurological Symptom Disorder
Conversion Disorder
Ketogenic Dieting
Lead sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 17
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: non epileptic seizure frequency
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Neurologia Y Neurocirugia Mvs
state: Ciudad De Mexico
Study officials:
affiliation: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
name: Edgar Crail Meléndez, MS
role: PRINCIPAL_INVESTIGATOR
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