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

NCT ID: NCT03775252

Last Updated: 2018-12-13

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-11-30

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.

Detailed Description

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Conditions

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Migraine Disorders

Keywords

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Ketogenic Diet

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ketogenic diet

Group of patients treated with ketogenic diet after the first neurophysiological screening.

Group Type EXPERIMENTAL

Ketogenic diet

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Cherubino DI LORENZO

Principal Investigator

Responsibility Role 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

Site Status

Countries

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Italy

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.

Reference Type RESULT
PMID: 27245682 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31228957 (View on PubMed)

Other Identifiers

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TrigeMigKeto

Identifier Type: -

Identifier Source: org_study_id