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

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Completed

CT.gov ID

NCT03775252

Collaborator

(none)

Enrollment

Location

Arm

10.9

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Migraine Disorders	Dietary Supplement: Ketogenic diet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jun 30, 2017

Actual Study Completion Date :

Nov 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketogenic diet Group of patients treated with ketogenic diet after the first neurophysiological screening.	Dietary Supplement: Ketogenic diet Diet rich in fats and poor in carbohydrate, to induce metabolic ketosis

Arm

Intervention/Treatment

Experimental: Ketogenic diet

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

Dietary Supplement: Ketogenic diet

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

Outcome Measures

Primary Outcome Measures

Trigeminal neurophysiological changes (amplitude) [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).
Trigeminal neurophysiological changes (latencies) [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).
Trigeminal neurophysiological changes (slope) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Policlinico Umberto I	Rome		Italy	00161

Sponsors and Collaborators

University of Roma La Sapienza

Investigators

Study Chair: francesco Pierelli, MD, Sapienza University of Rome

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cherubino DI LORENZO, Principal Investigator, University of Roma La Sapienza

ClinicalTrials.gov Identifier:

NCT03775252

Other Study ID Numbers:

TrigeMigKeto

First Posted:

Dec 13, 2018

Last Update Posted:

Dec 13, 2018

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cherubino DI LORENZO, Principal Investigator, University of Roma La Sapienza

Ketogenic Diet

Additional relevant MeSH terms:

Migraine Disorders

Study Results

No Results Posted as of Dec 13, 2018