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

NCT03775252 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-12-13

No results posted yet for this study

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.

Conditions

  • Migraine Disorders

Interventions

DIETARY_SUPPLEMENT

Ketogenic diet

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

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • francesco Pierelli, MD · University of Roma La Sapienza

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2017-06-30
Completion
2017-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03775252 on ClinicalTrials.gov