Non Epileptic SeizuresNCT05219006

Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures

A study testing ketogenic dieting and healthy dieting in people with Non Epileptic Seizures and Functional Neurological Symptom Disorder, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Non Epileptic Seizures, Functional Neurological Symptom Disorder, Conversion Disorder
What is being tested?: ketogenic dieting and healthy dieting
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteMexico
Study dates: 15 Jul 2021to 2 Jul 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 17 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Instituto Nacional de Neurologia Y Neurocirugia Mvs
Mexico City, Mexico City, 14269

Other trials in Mexico

About this study

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

Read the 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.

Conditions: Non Epileptic Seizures, Functional Neurological Symptom Disorder, Conversion Disorder, Ketogenic Dieting
Being tested: ketogenic dieting, healthy dieting
Medical subject headings: Seizures, Conversion Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05219006
Study group	Role	What they receive
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. Receives: 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 Receives: Dietary Supplement: healthy dieting

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 20212 Jul 2023

First posted1 Feb 2022
Study start15 Jul 2021
Primary completion20 May 2023
Study completion2 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (65)Papers the sponsor has linked to this study.
Other trials for Non Epileptic SeizuresStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05219006
Sponsor's protocol ID: 8/21
Status last verified: Sep 2023
First submitted: 20 Jan 2022
Last updated: 28 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Popkirov S, Asadi-Pooya AA, Duncan R, Gigineishvili D, Hingray C, Miguel Kanner A, LaFrance WC Jr, Pretorius C, Reuber M. The aetiology of psychogenic non-epileptic seizures: risk factors and comorbidities. Epileptic Disord. 2019 Dec 1;21(6):529-547. doi: 10.1684/epd.2019.1107.
PubMed 31843732
Avbersek A, Sisodiya S. Does the primary literature provide support for clinical signs used to distinguish psychogenic nonepileptic seizures from epileptic seizures? J Neurol Neurosurg Psychiatry. 2010 Jul;81(7):719-25. doi: 10.1136/jnnp.2009.197996.
PubMed 20581136
Kanemoto K, LaFrance WC Jr, Duncan R, Gigineishvili D, Park SP, Tadokoro Y, Ikeda H, Paul R, Zhou D, Taniguchi G, Kerr M, Oshima T, Jin K, Reuber M. PNES around the world: Where we are now and how we can close the diagnosis and treatment gaps-an ILAE PNES Task Force report. Epilepsia Open. 2017 Jun 23;2(3):307-316. doi: 10.1002/epi4.12060. eCollection 2017 Sep.
PubMed 29588959
Hingray C, Maillard L, Hubsch C, Vignal JP, Bourgognon F, Laprevote V, Lerond J, Vespignani H, Schwan R. Psychogenic nonepileptic seizures: characterization of two distinct patient profiles on the basis of trauma history. Epilepsy Behav. 2011 Nov;22(3):532-6. doi: 10.1016/j.yebeh.2011.08.015. Epub 2011 Oct 1.
PubMed 21962755
Sigurdardottir KR, Olafsson E. Incidence of psychogenic seizures in adults: a population-based study in Iceland. Epilepsia. 1998 Jul;39(7):749-52. doi: 10.1111/j.1528-1157.1998.tb01161.x.
PubMed 9670904
Stone J, Carson A, Duncan R, Roberts R, Warlow C, Hibberd C, Coleman R, Cull R, Murray G, Pelosi A, Cavanagh J, Matthews K, Goldbeck R, Smyth R, Walker J, Sharpe M. Who is referred to neurology clinics?--the diagnoses made in 3781 new patients. Clin Neurol Neurosurg. 2010 Nov;112(9):747-51. doi: 10.1016/j.clineuro.2010.05.011. Epub 2010 Jun 19.
PubMed 20646830
Benbadis SR, Allen Hauser W. An estimate of the prevalence of psychogenic non-epileptic seizures. Seizure. 2000 Jun;9(4):280-1. doi: 10.1053/seiz.2000.0409.
PubMed 10880289
Asadi-Pooya AA, Sperling MR. Epidemiology of psychogenic nonepileptic seizures. Epilepsy Behav. 2015 May;46:60-5. doi: 10.1016/j.yebeh.2015.03.015. Epub 2015 Apr 14.
PubMed 25882323
Goldstein LH, Robinson EJ, Reuber M, Chalder T, Callaghan H, Eastwood C, Landau S, McCrone P, Medford N, Mellers JDC, Moore M, Mosweu I, Murray J, Perdue I, Pilecka I, Richardson MP, Carson A, Stone J; CODES Study Group. Characteristics of 698 patients with dissociative seizures: A UK multicenter study. Epilepsia. 2019 Nov;60(11):2182-2193. doi: 10.1111/epi.16350. Epub 2019 Oct 13.
PubMed 31608436
Duncan R, Oto M, Wainman-Lefley J. Mortality in a cohort of patients with psychogenic non-epileptic seizures. J Neurol Neurosurg Psychiatry. 2012 Jul;83(7):761-2. doi: 10.1136/jnnp-2012-302900.
PubMed 22665451
LaFrance Jr W, Bjørnaes H. Designing treatment plans based on etiology of psychogenic nonepileptic seizures. Gates and Rowan's nonepilepfic seizures. 2010:266-80.
Brown RJ, Reuber M. Towards an integrative theory of psychogenic non-epileptic seizures (PNES). Clin Psychol Rev. 2016 Jul;47:55-70. doi: 10.1016/j.cpr.2016.06.003. Epub 2016 Jun 17. No abstract available.
PubMed 27340856
Reuber M, Brown RJ. Understanding psychogenic nonepileptic seizures-Phenomenology, semiology and the Integrative Cognitive Model. Seizure. 2017 Jan;44:199-205. doi: 10.1016/j.seizure.2016.10.029. Epub 2016 Nov 15.
PubMed 27988107
Devinsky O, Gazzola D, LaFrance WC Jr. Differentiating between nonepileptic and epileptic seizures. Nat Rev Neurol. 2011 Apr;7(4):210-20. doi: 10.1038/nrneurol.2011.24. Epub 2011 Mar 8.
PubMed 21386814
Brigo F, Nardone R, Ausserer H, Storti M, Tezzon F, Manganotti P, Bongiovanni LG. The diagnostic value of urinary incontinence in the differential diagnosis of seizures. Seizure. 2013 Mar;22(2):85-90. doi: 10.1016/j.seizure.2012.10.011. Epub 2012 Nov 9.
PubMed 23142708

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non Epileptic Seizures trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures in Patients With Dissociative Neurological Symptom Disorder: a Pilot Study
ClinicalTrials.gov ID: NCT05219006
Acronym / sponsor ID: 8/21
Conditions: Non Epileptic Seizures, Functional Neurological Symptom Disorder, Conversion Disorder, Ketogenic Dieting
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezUniversity, hospital or other
Study start: 15 Jul 2021 (actual)
Primary completion: 20 May 2023 (actual)
Study completion: 2 Jul 2023 (actual)
First posted: 1 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ketogenic dieting + conventional treatment	Experimental	Dietary Supplement: ketogenic dietingNutrition 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.
Healthy dieting + conventional treatment	Active comparator	Dietary Supplement: healthy dietingIn 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

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ketogenic dietingAtkins modified diet: 1.2-1.5 g/kg/day of protein with a ratio 1:1 (fat: carbohydrate + protein)	Dietary supplement	ketogenic dieting + conventional treatment
healthy dietingNormocaloric 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.	Dietary supplement	Healthy dieting + conventional treatment

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Background: PubMed 31843732Popkirov S, Asadi-Pooya AA, Duncan R, Gigineishvili D, Hingray C, Miguel Kanner A, LaFrance WC Jr, Pretorius C, Reuber M. The aetiology of psychogenic non-epileptic seizures: risk factors and comorbidities. Epileptic Disord. 2019 Dec 1;21(6):529-547. doi: 10.1684/epd.2019.1107.
Background: PubMed 20581136Avbersek A, Sisodiya S. Does the primary literature provide support for clinical signs used to distinguish psychogenic nonepileptic seizures from epileptic seizures? J Neurol Neurosurg Psychiatry. 2010 Jul;81(7):719-25. doi: 10.1136/jnnp.2009.197996.
Background: PubMed 29588959Kanemoto K, LaFrance WC Jr, Duncan R, Gigineishvili D, Park SP, Tadokoro Y, Ikeda H, Paul R, Zhou D, Taniguchi G, Kerr M, Oshima T, Jin K, Reuber M. PNES around the world: Where we are now and how we can close the diagnosis and treatment gaps-an ILAE PNES Task Force report. Epilepsia Open. 2017 Jun 23;2(3):307-316. doi: 10.1002/epi4.12060. eCollection 2017 Sep.
Background: PubMed 21962755Hingray C, Maillard L, Hubsch C, Vignal JP, Bourgognon F, Laprevote V, Lerond J, Vespignani H, Schwan R. Psychogenic nonepileptic seizures: characterization of two distinct patient profiles on the basis of trauma history. Epilepsy Behav. 2011 Nov;22(3):532-6. doi: 10.1016/j.yebeh.2011.08.015. Epub 2011 Oct 1.
Background: PubMed 9670904Sigurdardottir KR, Olafsson E. Incidence of psychogenic seizures in adults: a population-based study in Iceland. Epilepsia. 1998 Jul;39(7):749-52. doi: 10.1111/j.1528-1157.1998.tb01161.x.
Background: PubMed 20646830Stone J, Carson A, Duncan R, Roberts R, Warlow C, Hibberd C, Coleman R, Cull R, Murray G, Pelosi A, Cavanagh J, Matthews K, Goldbeck R, Smyth R, Walker J, Sharpe M. Who is referred to neurology clinics?--the diagnoses made in 3781 new patients. Clin Neurol Neurosurg. 2010 Nov;112(9):747-51. doi: 10.1016/j.clineuro.2010.05.011. Epub 2010 Jun 19.
Background: PubMed 10880289Benbadis SR, Allen Hauser W. An estimate of the prevalence of psychogenic non-epileptic seizures. Seizure. 2000 Jun;9(4):280-1. doi: 10.1053/seiz.2000.0409.
Background: PubMed 25882323Asadi-Pooya AA, Sperling MR. Epidemiology of psychogenic nonepileptic seizures. Epilepsy Behav. 2015 May;46:60-5. doi: 10.1016/j.yebeh.2015.03.015. Epub 2015 Apr 14.
Background: PubMed 31608436Goldstein LH, Robinson EJ, Reuber M, Chalder T, Callaghan H, Eastwood C, Landau S, McCrone P, Medford N, Mellers JDC, Moore M, Mosweu I, Murray J, Perdue I, Pilecka I, Richardson MP, Carson A, Stone J; CODES Study Group. Characteristics of 698 patients with dissociative seizures: A UK multicenter study. Epilepsia. 2019 Nov;60(11):2182-2193. doi: 10.1111/epi.16350. Epub 2019 Oct 13.
Background: PubMed 22665451Duncan R, Oto M, Wainman-Lefley J. Mortality in a cohort of patients with psychogenic non-epileptic seizures. J Neurol Neurosurg Psychiatry. 2012 Jul;83(7):761-2. doi: 10.1136/jnnp-2012-302900.
BackgroundLaFrance Jr W, Bjørnaes H. Designing treatment plans based on etiology of psychogenic nonepileptic seizures. Gates and Rowan's nonepilepfic seizures. 2010:266-80.
Background: PubMed 27340856Brown RJ, Reuber M. Towards an integrative theory of psychogenic non-epileptic seizures (PNES). Clin Psychol Rev. 2016 Jul;47:55-70. doi: 10.1016/j.cpr.2016.06.003. Epub 2016 Jun 17. No abstract available.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Edgar Crail Meléndez, MS principal investigator

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

non epileptic seizure frequency (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05219006, which also lists 65 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.