Trials / Completed
CompletedNCT03775252
A Ketogenic Diet Acts on Cortical But Not Subcortical Responsivity in Migraineurs
A Ketogenic Diet Normalizes Interictal Cortical But Not Subcortical Responsivity in Migraineurs
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- University of Roma La Sapienza · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Ketogenic diet | Diet rich in fats and poor in carbohydrate, to induce metabolic ketosis |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2017-06-30
- Completion
- 2017-11-30
- First posted
- 2018-12-13
- Last updated
- 2018-12-13
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03775252. Inclusion in this directory is not an endorsement.