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

Migraine Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03775252
• Other study ID #: TrigeMigKeto
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: December 2018
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Dietary Supplement:
• Ketogenic diet
Diet rich in fats and poor in carbohydrate, to induce metabolic ketosis

Locations

Country	Name	City	State
Italy	Policlinico Umberto I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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