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

NCT03775252 | Completed

• 1 other identifier: TrigeMigKeto
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders

Keywords

Ketogenic Diet

Outcome Measures

Primary Outcomes (3)

• Trigeminal neurophysiological changes (amplitude)

  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).

  one month

• Trigeminal neurophysiological changes (latencies)

  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).

  one month

• Trigeminal neurophysiological changes (slope)

  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.

  one month

Study Arms (1)

Ketogenic diet

EXPERIMENTAL

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

Dietary Supplement: Ketogenic diet

Interventions

Ketogenic diet DIETARY_SUPPLEMENT

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

Ketogenic diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of migraine
• Kept a headache diary for at least 1 month
• Headache onset before the age of 50

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Policlinico Umberto I

Rome, 00161, Italy

Location

Related Publications (2)

• 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.

  PMID: 27245682 RESULT

• 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.

  PMID: 31228957 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• francesco Pierelli, MD

  University of Roma La Sapienza

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 13, 2018
• Study Start: January 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: November 30, 2017
• Last Updated: December 13, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)