MigraineNCT06599905
Pain Control in Episodic and Chronic Migraine
A study testing Episodic Migraine (EM) and Chronic Migraine (CM) in people with Migraine, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
Trial summary
The phenomenon of offset analgesia (OA) refers to a disproportionately large decrease in perceived pain following a slight reduction in the intensity of a noxious heat stimulus. This phenomenon is considered as an indicator of the activation of the endogenous pain modulation system, whose dysfunction is implicated in… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Episodic Migraine (EM) and Chronic Migraine (CM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2021to 15 Apr 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients affected by episodic or chronic migraine according to the International Headache Society (IHS) Classification (3rd edition), aged 18 to 70 years
Who cannot join
- any other headache diagnosis according to the IHS classification
- other acute or chronic pain conditions
- serious internal, psychiatric, or neurological systemic diseases
- pregnancy, breastfeeding, skin pathologies in the tested trigeminal nerve area (V1)
- poor sleep quality the night before testing
- alcohol consumption or intense exercise within 24 hours prior to examination
- women were not assessed during their menstrual cycle.
- Use of migraine prophylactic medication for patients with EM.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endogenous Pain Control Mechanisms Throughout the Migraine Cycle and in Chronic Migraine
The phenomenon of offset analgesia (OA) refers to a disproportionately large decrease in perceived pain following a slight reduction in the intensity of a noxious heat stimulus. This phenomenon is considered as an indicator of the activation of the endogenous pain modulation system, whose dysfunction is implicated in the pathophysiology of migraine and other chronic pain conditions. This study aims to investigate pain processing mechanisms using the OA paradigm in individuals with episodic migraine (EM) during different phases of the migraine cycle and in those with chronic migraine (CM), with and without medication overuse headache (CMwoMOH and CM-MOH, respectively). A population of healthy subjects matched by sex and age will also be enrolled
Read the detailed description
Migraine is a cyclic disorder marked by varying activity in different brain regions. It is generally believed that migraine involves a pronociceptive pain modulation pattern, likely due to impaired endogenous pain inhibitory systems. However, there are few studies in this respect, and different experimental approaches have produced mixed results, showing both normal and abnormal pain responses in migraine. Most research has focused only on episodic migraine (EM) during headache-free periods, leaving the role of pain modulation dysfunction in recurring migraines and the progression to chronic migraine unexplored. Conditioned Pain Modulation (CPM) tests, which measure the "pain inhibits pain" effect, are commonly used to assess inhibitory pain modulation. Studies comparing CPM responses in migraine sufferers and healthy individuals have yielded inconsistent findings, with some showing reduced inhibitory responses in migraineurs, while others found no difference. Offset Analgesia (OA) is another method used to study descending pain modulation systems in chronic pain conditions. Unlike CPM, OA examines temporal filtering of pain when dynamic noxious stimuli are applied and is characterized by a large reduction in pain sensation after a small decrease in a heat stimulus. Research indicates that central mechanisms, including the activation of descending pain modulatory and reward systems, play a significant role in OA. Only one study has explored the OA response in episodic migraine patients during headache-free intervals, finding no inhibitory pain modulation in the trigeminal area. This study aims to: 1) assess changes in pain modulation across the migraine cycle in EM patients, and 2) determine if different dysfunctional pain modulation patterns are present in chronic migraine, both with and without medication-overuse headache (CMwoMOH and CM-MOH).
Subjects and methods. The investigators will enroll 30 subjects with EM, 30 patients with CM (with and without MOH), and 30 healthy control subjects. Patients with EM during the preictal, ictal, and postictal phases will be also enrolled. All participants underwent an experimental paradigm consisting of three stimulus offset trials (OT) and three constant temperature trials (CT) applied to the forehead based on the individual heat pain threshold (HPT). All tests will be carried out by using a Q-sense CPM device (Medoc) and computerized visual analogue scale (CoVAS).
Experimental paradigms. All subjects will be assessed in a single experimental session. After obtaining written consent, participants will complete various questionnaires. The Heat Pain Threshold (HPT) will be then measured on the forehead (1st branch of the trigeminal nerve, V1), followed by three constant trials (CT) and three offset-analgesia trials (OT) in the same area. The following questionnaires will be administered: 12-item Allodynia Symptom Checklist (ASC-12), Migraine Disability Assessment (MIDAS), and Hospital Anxiety and Depression Scale (HADS).
- Conditions
- Migraine
- Being tested
- Episodic Migraine (EM), Chronic Migraine (CM)
- Keywords
- migraine, pain, offset analgesia, chronification
- Medical subject headings
- Migraine Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episodic Migraine (EM)Other
Three stimulus offset trials (OT) and three constant temperature trials (CT) applied to the forehead based on the individual heat pain threshold (HPT).
Chronic Migraine (CM)Other
Three stimulus offset trials (OT) and three constant temperature trials (CT) applied to the forehead based on the individual heat pain threshold (HPT).
| Study group | Role | What they receive |
|---|---|---|
| Group with episodic migraine (EM) | Experimental | Subjects with episodic migraine (EM) with or without aura according to the International Headache Society (IHS) Classification (3rd edition). Receives: Other: Chronic Migraine (CM) |
| Group with chronic migraine (EC) | Experimental | Subjects with chronic migraine (CM) with or without Medication Overuse (MO) according to the International Headache Society (IHS) Classification (3rd edition). Receives: Other: Episodic Migraine (EM) |
| Control group | Other | Age- and sex-matched controls. Receives: Other: Episodic Migraine (EM); Other: Chronic Migraine (CM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Offset analgesia paradigm
Differences in pain scores on the Visual Analog Scale and during the offset analgesia trial and the constant trials in patients with episodic migraine evaluated in the interictal period compared to patients with chronic migraine (with or without medication overuse) and healthy control subjects matched for sex and age
Measured: Through study completion, an average of 2 years
Secondary outcomes (2)
Offset analgesia paradigm in different phase of episodic migraine
Differences in pain scores on the Visual Analog Scale and during the offset analgesia trial and the constant trials in patients with episodic migraine evaluated in different phases of the migraine cycle (interictal, preictal, ictal, postictal).
Measured: Through study completion, an average of 2 years
Offset analgesia paradigm in chronic migraine with or without medication overuse headache
Differences in pain scores on the Visual Analog Scale and during the offset analgesia trial and the constant trials in patients suffering from chronic migraine with or without medication overuse headache.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Jun 2021
- Primary completion15 Jan 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- To evaluate differences in the response to offset analgesia (OA) paradigm between episodic and chronic migraine patients and controls
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Cosentino, MD, Principal investigator, Translational Neurophysiology - Headache and Neurorehabilitation Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599905
- Sponsor's protocol ID
- MigOA
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cosentino G, Fierro B, Vigneri S, Talamanca S, Paladino P, Baschi R, Indovino S, Maccora S, Valentino F, Fileccia E, Giglia G, Brighina F. Cyclical changes of cortical excitability and metaplasticity in migraine: evidence from a repetitive transcranial magnetic stimulation study. Pain. 2014 Jun;155(6):1070-1078. doi: 10.1016/j.pain.2014.02.024. Epub 2014 Mar 13.
PubMed 24631596Schulte LH, May A. The migraine generator revisited: continuous scanning of the migraine cycle over 30 days and three spontaneous attacks. Brain. 2016 Jul;139(Pt 7):1987-93. doi: 10.1093/brain/aww097. Epub 2016 May 5.
PubMed 27190019Tassorelli C, Greco R, Silberstein SD. The endocannabinoid system in migraine: from bench to pharmacy and back. Curr Opin Neurol. 2019 Jun;32(3):405-412. doi: 10.1097/WCO.0000000000000688.
PubMed 30883435Szikszay TM, Adamczyk WM, Carvalho GF, May A, Luedtke K. Offset analgesia: somatotopic endogenous pain modulation in migraine. Pain. 2020 Mar;161(3):557-564. doi: 10.1097/j.pain.0000000000001739.
PubMed 31693545de Tommaso M, Losito L, Difruscolo O, Sardaro M, Libro G, Guido M, Lamberti P, Livrea P. Capsaicin failed in suppressing cortical processing of CO2 laser pain in migraine patients. Neurosci Lett. 2005 Aug 12-19;384(1-2):150-5. doi: 10.1016/j.neulet.2005.04.086.
PubMed 15927376de Tommaso M, Difruscolo O, Sardaro M, Libro G, Pecoraro C, Serpino C, Lamberti P, Livrea P. Effects of remote cutaneous pain on trigeminal laser-evoked potentials in migraine patients. J Headache Pain. 2007 Jun;8(3):167-74. doi: 10.1007/s10194-007-0385-8. Epub 2007 Jun 11.
PubMed 17563842Coppola G, Di Clemente L, Fumal A, Magis D, De Pasqua V, Pierelli F, Schoenen J. Inhibition of the nociceptive R2 blink reflex after supraorbital or index finger stimulation is normal in migraine without aura between attacks. Cephalalgia. 2007 Jul;27(7):803-8. doi: 10.1111/j.1468-2982.2007.01323.x.
PubMed 17598762Perrotta A, Serrao M, Sandrini G, Burstein R, Sances G, Rossi P, Bartolo M, Pierelli F, Nappi G. Sensitisation of spinal cord pain processing in medication overuse headache involves supraspinal pain control. Cephalalgia. 2010 Mar;30(3):272-84. doi: 10.1111/j.1468-2982.2009.01914.x. Epub 2010 Feb 15.
PubMed 19614707Grill JD, Coghill RC. Transient analgesia evoked by noxious stimulus offset. J Neurophysiol. 2002 Apr;87(4):2205-8. doi: 10.1152/jn.00730.2001.
PubMed 11929939Ligato D, Petersen KK, Morch CD, Arendt-Nielsen L. Offset analgesia: The role of peripheral and central mechanisms. Eur J Pain. 2018 Jan;22(1):142-149. doi: 10.1002/ejp.1110. Epub 2017 Sep 12.
PubMed 28898500
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endogenous Pain Control Mechanisms Throughout the Migraine Cycle and in Chronic Migraine
- ClinicalTrials.gov ID
- NCT06599905
- Acronym / sponsor ID
- MigOA
- Conditions
- Migraine
- Keywords
- migraine, pain, offset analgesia, chronification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 19 Sep 2024 (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.
The phenomenon of offset analgesia (OA) refers to a disproportionately large decrease in perceived pain following a slight reduction in the intensity of a noxious heat stimulus. This phenomenon is considered as an indicator of the activation of the endogenous pain modulation system, whose dysfunction is implicated in the pathophysiology of migraine and other chronic pain conditions. This study aims to investigate pain processing mechanisms using the OA paradigm in individuals with episodic migraine (EM) during different phases of the migraine cycle and in those with chronic migraine (CM), with and without medication overuse headache (CMwoMOH and CM-MOH, respectively). A population of healthy subjects matched by sex and age will also be enrolled
Detailed description
Migraine is a cyclic disorder marked by varying activity in different brain regions. It is generally believed that migraine involves a pronociceptive pain modulation pattern, likely due to impaired endogenous pain inhibitory systems. However, there are few studies in this respect, and different experimental approaches have produced mixed results, showing both normal and abnormal pain responses in migraine. Most research has focused only on episodic migraine (EM) during headache-free periods, leaving the role of pain modulation dysfunction in recurring migraines and the progression to chronic migraine unexplored. Conditioned Pain Modulation (CPM) tests, which measure the "pain inhibits pain" effect, are commonly used to assess inhibitory pain modulation. Studies comparing CPM responses in migraine sufferers and healthy individuals have yielded inconsistent findings, with some showing reduced inhibitory responses in migraineurs, while others found no difference. Offset Analgesia (OA) is another method used to study descending pain modulation systems in chronic pain conditions. Unlike CPM, OA examines temporal filtering of pain when dynamic noxious stimuli are applied and is characterized by a large reduction in pain sensation after a small decrease in a heat stimulus. Research indicates that central mechanisms, including the activation of descending pain modulatory and reward systems, play a significant role in OA. Only one study has explored the OA response in episodic migraine patients during headache-free intervals, finding no inhibitory pain modulation in the trigeminal area. This study aims to: 1) assess changes in pain modulation across the migraine cycle in EM patients, and 2) determine if different dysfunctional pain modulation patterns are present in chronic migraine, both with and without medication-overuse headache (CMwoMOH and CM-MOH).
Subjects and methods. The investigators will enroll 30 subjects with EM, 30 patients with CM (with and without MOH), and 30 healthy control subjects. Patients with EM during the preictal, ictal, and postictal phases will be also enrolled. All participants underwent an experimental paradigm consisting of three stimulus offset trials (OT) and three constant temperature trials (CT) applied to the forehead based on the individual heat pain threshold (HPT). All tests will be carried out by using a Q-sense CPM device (Medoc) and computerized visual analogue scale (CoVAS).
Experimental paradigms. All subjects will be assessed in a single experimental session. After obtaining written consent, participants will complete various questionnaires. The Heat Pain Threshold (HPT) will be then measured on the forehead (1st branch of the trigeminal nerve, V1), followed by three constant trials (CT) and three offset-analgesia trials (OT) in the same area. The following questionnaires will be administered: 12-item Allodynia Symptom Checklist (ASC-12), Migraine Disability Assessment (MIDAS), and Hospital Anxiety and Depression Scale (HADS).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- To evaluate differences in the response to offset analgesia (OA) paradigm between episodic and chronic migraine patients and controls
| Arm | Type | Receives |
|---|---|---|
| Group with episodic migraine (EM) | Experimental | Other: Chronic Migraine (CM)Subjects with episodic migraine (EM) with or without aura according to the International Headache Society (IHS) Classification (3rd edition). |
| Group with chronic migraine (EC) | Experimental | Other: Episodic Migraine (EM)Subjects with chronic migraine (CM) with or without Medication Overuse (MO) according to the International Headache Society (IHS) Classification (3rd edition). |
| Control group | Other | Other: Episodic Migraine (EM), Other: Chronic Migraine (CM)Age- and sex-matched controls. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients affected by episodic or chronic migraine according to the International Headache Society (IHS) Classification (3rd edition), aged 18 to 70 years
Key exclusion criteria (8 listed)
- any other headache diagnosis according to the IHS classification
- other acute or chronic pain conditions
- serious internal, psychiatric, or neurological systemic diseases
- pregnancy, breastfeeding, skin pathologies in the tested trigeminal nerve area (V1)
- poor sleep quality the night before testing
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 |
|---|---|---|
| Episodic Migraine (EM)Three stimulus offset trials (OT) and three constant temperature trials (CT) applied to the forehead based on the individual heat pain threshold (HPT). | Other | Control group, Group with chronic migraine (EC) |
| Chronic Migraine (CM)Three stimulus offset trials (OT) and three constant temperature trials (CT) applied to the forehead based on the individual heat pain threshold (HPT). | Other | Control group, Group with episodic migraine (EM) |
Primary outcome
Offset analgesia paradigm
Time frame: Through study completion, an average of 2 years
Differences in pain scores on the Visual Analog Scale and during the offset analgesia trial and the constant trials in patients with episodic migraine evaluated in the interictal period compared to patients with chronic migraine (with or without medication overuse) and healthy control subjects matched for sex and age
2 secondary outcomes
Offset analgesia paradigm in different phase of episodic migraine
Time frame: Through study completion, an average of 2 years
Offset analgesia paradigm in chronic migraine with or without medication overuse headache
Time frame: Through study completion, an average of 2 years
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 19 Sep 2024.
- Background: PubMed 24631596Cosentino G, Fierro B, Vigneri S, Talamanca S, Paladino P, Baschi R, Indovino S, Maccora S, Valentino F, Fileccia E, Giglia G, Brighina F. Cyclical changes of cortical excitability and metaplasticity in migraine: evidence from a repetitive transcranial magnetic stimulation study. Pain. 2014 Jun;155(6):1070-1078. doi: 10.1016/j.pain.2014.02.024. Epub 2014 Mar 13.
- Background: PubMed 27190019Schulte LH, May A. The migraine generator revisited: continuous scanning of the migraine cycle over 30 days and three spontaneous attacks. Brain. 2016 Jul;139(Pt 7):1987-93. doi: 10.1093/brain/aww097. Epub 2016 May 5.
- Background: PubMed 30883435Tassorelli C, Greco R, Silberstein SD. The endocannabinoid system in migraine: from bench to pharmacy and back. Curr Opin Neurol. 2019 Jun;32(3):405-412. doi: 10.1097/WCO.0000000000000688.
- Background: PubMed 31693545Szikszay TM, Adamczyk WM, Carvalho GF, May A, Luedtke K. Offset analgesia: somatotopic endogenous pain modulation in migraine. Pain. 2020 Mar;161(3):557-564. doi: 10.1097/j.pain.0000000000001739.
- Background: PubMed 15927376de Tommaso M, Losito L, Difruscolo O, Sardaro M, Libro G, Guido M, Lamberti P, Livrea P. Capsaicin failed in suppressing cortical processing of CO2 laser pain in migraine patients. Neurosci Lett. 2005 Aug 12-19;384(1-2):150-5. doi: 10.1016/j.neulet.2005.04.086.
- Background: PubMed 17563842de Tommaso M, Difruscolo O, Sardaro M, Libro G, Pecoraro C, Serpino C, Lamberti P, Livrea P. Effects of remote cutaneous pain on trigeminal laser-evoked potentials in migraine patients. J Headache Pain. 2007 Jun;8(3):167-74. doi: 10.1007/s10194-007-0385-8. Epub 2007 Jun 11.
- Background: PubMed 17598762Coppola G, Di Clemente L, Fumal A, Magis D, De Pasqua V, Pierelli F, Schoenen J. Inhibition of the nociceptive R2 blink reflex after supraorbital or index finger stimulation is normal in migraine without aura between attacks. Cephalalgia. 2007 Jul;27(7):803-8. doi: 10.1111/j.1468-2982.2007.01323.x.
- Background: PubMed 19614707Perrotta A, Serrao M, Sandrini G, Burstein R, Sances G, Rossi P, Bartolo M, Pierelli F, Nappi G. Sensitisation of spinal cord pain processing in medication overuse headache involves supraspinal pain control. Cephalalgia. 2010 Mar;30(3):272-84. doi: 10.1111/j.1468-2982.2009.01914.x. Epub 2010 Feb 15.
- Background: PubMed 11929939Grill JD, Coghill RC. Transient analgesia evoked by noxious stimulus offset. J Neurophysiol. 2002 Apr;87(4):2205-8. doi: 10.1152/jn.00730.2001.
- Background: PubMed 28898500Ligato D, Petersen KK, Morch CD, Arendt-Nielsen L. Offset analgesia: The role of peripheral and central mechanisms. Eur J Pain. 2018 Jan;22(1):142-149. doi: 10.1002/ejp.1110. Epub 2017 Sep 12.
- Individual participant dataSharing planned: No
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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.
Giuseppe Cosentino, MD principal investigator
Translational Neurophysiology - Headache and Neurorehabilitation Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Episodic Migraine (EM) and Chronic Migraine (CM) in people with Migraine, run by IRCCS National Neurological Institute "C. Mondino" Foundation 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 1 inclusion and 8 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 19 Sep 2024. 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?
Offset analgesia paradigm (time frame: Through study completion, an average of 2 years). 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 NCT06599905, which also lists 10 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 19 Sep 2024.