Migraine DisordersNCT03775252
A Ketogenic Diet Acts on Cortical But Not Subcortical Responsivity in Migraineurs
A study testing Ketogenic diet in people with Migraine Disorders, run by University of Roma La Sapienza at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of migraine
- Kept a headache diary for at least 1 month
- Headache onset before the age of 50
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Ketogenic Diet Normalizes Interictal Cortical But Not Subcortical Responsivity in Migraineurs
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
- Being tested
- Ketogenic diet
- Keywords
- Ketogenic Diet
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietDietary supplement
Diet rich in fats and poor in carbohydrate, to induce metabolic ketosis
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Experimental | Group of patients treated with ketogenic diet after the first neurophysiological screening. Receives: Dietary Supplement: Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Jan 2017
- Primary completion30 Jun 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cherubino DI LORENZO, University of Roma La Sapienza
- Investigators
- francesco Pierelli, MD, Study chair, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775252
- Sponsor's protocol ID
- TrigeMigKeto
- Status last verified
- Dec 2018
- First submitted
- 9 Dec 2018
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no sharing
Publications
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.
PubMed 27245682Di 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.
PubMed 31228957
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Ketogenic Diet Normalizes Interictal Cortical But Not Subcortical Responsivity in Migraineurs
- ClinicalTrials.gov ID
- NCT03775252
- Acronym / sponsor ID
- TrigeMigKeto
- Conditions
- Migraine Disorders
- Keywords
- Ketogenic Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Experimental | Dietary Supplement: Ketogenic dietGroup of patients treated with ketogenic diet after the first neurophysiological screening. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of migraine
- Kept a headache diary for at least 1 month
- Headache onset before the age of 50
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic dietDiet rich in fats and poor in carbohydrate, to induce metabolic ketosis | Dietary supplement | Ketogenic diet |
Primary outcome
Trigeminal neurophysiological changes (amplitude)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Results publication: PubMed 27245682Di 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.
- Derived from this study: PubMed 31228957Di 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.
- Individual participant dataSharing planned: No. There will be no sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
francesco Pierelli, MD study chair
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet in people with Migraine Disorders, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trigeminal neurophysiological changes (amplitude) (time frame: one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03775252, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.