A Ketogenic Diet Acts on Cortical But Not Subcortical Responsivity in Migraineurs
NCT ID: NCT03775252
Last Updated: 2018-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2017-01-01
2017-11-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Ketogenic diet
Group of patients treated with ketogenic diet after the first neurophysiological screening.
Ketogenic diet
Diet rich in fats and poor in carbohydrate, to induce metabolic ketosis
Interventions
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Ketogenic diet
Diet rich in fats and poor in carbohydrate, to induce metabolic ketosis
Eligibility Criteria
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Inclusion Criteria
* Kept a headache diary for at least 1 month
* Headache onset before the age of 50
Exclusion Criteria
* pregnancy or lactation
* type I diabetes
* serious organic or psychiatric disorders that the investigators judged as having the potential to influence the trial evaluation.
18 Years
65 Years
ALL
Yes
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Cherubino DI LORENZO
Principal Investigator
Principal Investigators
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francesco Pierelli, MD
Role: STUDY_CHAIR
University of Roma La Sapienza
Locations
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Policlinico Umberto I
Rome, , Italy
Countries
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References
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Di Lorenzo C, Coppola G, Bracaglia M, Di Lenola D, Evangelista M, Sirianni G, Rossi P, Di Lorenzo G, Serrao M, Parisi V, Pierelli F. Cortical functional correlates of responsiveness to short-lasting preventive intervention with ketogenic diet in migraine: a multimodal evoked potentials study. J Headache Pain. 2016;17:58. doi: 10.1186/s10194-016-0650-9. Epub 2016 May 31.
Di Lorenzo C, Coppola G, Bracaglia M, Di Lenola D, Sirianni G, Rossi P, Di Lorenzo G, Parisi V, Serrao M, Cervenka MC, Pierelli F. A ketogenic diet normalizes interictal cortical but not subcortical responsivity in migraineurs. BMC Neurol. 2019 Jun 22;19(1):136. doi: 10.1186/s12883-019-1351-1.
Other Identifiers
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TrigeMigKeto
Identifier Type: -
Identifier Source: org_study_id
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