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Completed

NCT Number: NCT03775252

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

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.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico Umberto I

Rome, 00161, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketogenic diet

Dietary Supplement

Diet rich in fats and poor in carbohydrate, to induce metabolic ketosis

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2018
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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