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

Study Overview
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Brief Summary
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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.

Official Title
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A Ketogenic Diet Normalizes Interictal Cortical But Not Subcortical Responsivity in Migraineurs

Conditions
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Migraine Disorders

Intervention / Treatment
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* Dietary Supplement: Ketogenic diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketogenic diet<br>Group of patients treated with ketogenic diet after the first neurophysiological screening. | Dietary Supplement: Ketogenic diet<br>* Diet rich in fats and poor in carbohydrate, to induce metabolic ketosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trigeminal neurophysiological changes (amplitude) | 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). | one month | 
| Trigeminal neurophysiological changes (latencies) | 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). | one month | 
| Trigeminal neurophysiological changes (slope) | 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. | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketogenic Diet