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A Ketogenic Diet Acts on Cortical But Not Subcortical Responsivity in Migraineurs

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ClinicalTrials.gov Identifier: NCT03775252
Recruitment Status : Completed
First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Cherubino DI LORENZO, University of Roma La Sapienza

Brief Summary:

A short ketogenic diet (KD) treatment can prevent migraine attacks and correct excessive cortical response. Here, investigators aim to prove if the KD-related changes of cortical excitability are primarily due to cerebral cortex activity or are modulated by the brainstem.

Through the stimulation of the right supraorbital division of the trigeminal nerve, there will be concurrently interictally recorded the nociceptive blink reflex (nBR) and the pain-related evoked potentials (PREP) in 18 migraineurs patients without aura before and after 1-month on KD, while in metabolic ketosis. nBR and PREP reflect distinct brain structures activation: the brainstem and the cerebral cortex respectively. It will be estimated nBR R2 component area-under-the-curve as well as PREP amplitude habituation as the slope of the linear regression between the 1st and the 2nd block of 5 averaged responses.


Condition or disease Intervention/treatment Phase
Migraine Disorders Dietary Supplement: Ketogenic diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Ketogenic Diet Normalizes Interictal Cortical But Not Subcortical Responsivity in Migraineurs
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Ketogenic diet
Group of patients treated with ketogenic diet after the first neurophysiological screening.
Dietary Supplement: Ketogenic diet
Diet rich in fats and poor in carbohydrate, to induce metabolic ketosis




Primary Outcome Measures :
  1. Trigeminal neurophysiological changes (amplitude) [ Time Frame: one month ]
    Comparison before and during ketogenic diet of trigeminal neurophysiological features in a population of patients with migraine. In particular, the nociceptive blink reflex (nBR) and the trigeminal pain-related evoked potentials (PREPs) changes of amplitude between the baseline (pre-diet) and during the diet will be used as markers of ketones activity on neural modulation. The unit of measure of the amplitude of neurophysiological evoked responses are the micronVolts (1 volt X 10^-6).

  2. Trigeminal neurophysiological changes (latencies) [ Time Frame: one month ]
    Comparison before and during ketogenic diet of latencies of trigeminal neurophysiological evoked responses in a population of patients with migraine. In particular, the latency of evoked nociceptive blink reflex (nBR) and the trigeminal pain-related evoked potentials (PREPs) changes between the baseline (pre-diet) and during the diet. The unit of measure of the latency of the neurophysiological features are the milliseconds (1 sec X 10^-3).

  3. Trigeminal neurophysiological changes (slope) [ Time Frame: one month ]
    Comparison before and during ketogenic diet of the habituation slope of amplitudes of repeated responses to repetitive trigeminal painful electrical stimuli in a population of patients with migraine. A repetitive stimulus induces repetitive responses from the brainstem and cerebral cortex that physiologically have a decremental trend of amplitudes, also called habituation. On the contrary, in migraineurs, there is a deficit of habituation, i.e. a lack of decremental responses, both in nociceptive blink reflex (nBR) and the trigeminal pain-related evoked potentials (PREPs). The changes induced by ketogenic diet in habituation slope will be measured. The unit of measure of the slope is the radiant degree.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of migraine
  • Kept a headache diary for at least 1 month
  • Headache onset before the age of 50

Exclusion Criteria:

  • over consumption of acute pain-killers (triptan, analgesic, or ergotamine)
  • pregnancy or lactation
  • type I diabetes
  • serious organic or psychiatric disorders that the investigators judged as having the potential to influence the trial evaluation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775252


Locations
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Italy
Policlinico Umberto I
Rome, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Study Chair: francesco Pierelli, MD Sapienza University of Rome
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cherubino DI LORENZO, Principal Investigator, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03775252    
Other Study ID Numbers: TrigeMigKeto
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There will be no sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cherubino DI LORENZO, University of Roma La Sapienza:
Ketogenic Diet
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases