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

U

University of Roma La Sapienza

Status

Completed

Conditions

Migraine Disorders

Treatments

Dietary Supplement: Ketogenic diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03775252
TrigeMigKeto

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Ketogenic diet
Experimental group
Description:
Group of patients treated with ketogenic diet after the first neurophysiological screening.
Treatment:
Dietary Supplement: Ketogenic diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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