MigraineNCT01395264
Saccadometry in Primary Headache Syndromes
An observational study of Migraine and Cluster Headache, run by Tim Young at 2 sites in United Kingdom.
Trial summary
Migraine is one of the commonest neurological disorders, affecting up to 12% of the general population, but remains relatively under-diagnosed and under-treated. Migraine has a wide socioeconomic impact and brings a large economic burden; estimates suggest that disability due to migraine costs > €27 billion per annum… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine, Cluster Headache, Control
- How many people
- 42 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2011to 27 Oct 2017
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: From hospital Headache clinics (secondary and tertiary)
Who may be able to join
- Male or female and aged between 18 and 60 years in good general health apart from suffering from headaches (test group).
- Migraine and cluster headache will be diagnosed according to ICHD-II diagnostic criteria (6).
- Migraineurs must suffer at least two migraine attacks per year and no more than 5 attacks per month.
- -
Who cannot join
- Any other neurological disorder such as stroke, multiple sclerosis, epilepsy, concussion within the past year, psychiatric disorders, visual disorders.
- Use of migraine prophylactic medication in the last month or acute migraine therapy in the 3 days prior to testing.
- Patients on any medication to treat depression in their case
- Headache during testing or within 3 days before and after testing.
- -
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Neurology Department, Whittington Hospital
London, N19 5NF
The National Hospital for Neurology and Neurosurgery, London WC1N 3BG, and The John Radcliffe hospital, Oxford, The Whittington Hospital N19 5NF London
London, WC1N 3BG
About this study
Migraine is one of the commonest neurological disorders, affecting up to 12% of the general population, but remains relatively under-diagnosed and under-treated. Migraine has a wide socioeconomic impact and brings a large economic burden; estimates suggest that disability due to migraine costs > €27 billion per annum across Europe. Despite its prevalence and impact, migraine pathophysiology is poorly understood. A wider understanding of the functional changes in this disorder would be beneficial to both diagnosis and treatment.
Saccades are the rapid eye movements we make when moving the eyes to a new object in our visual field. Reaction time studies have been used to investigate Huntington's disease and Parkinson's disease with great success. These use saccadic tasks (monitoring eye movements). Even at rest we make approximately three saccades per second, so a lot of data can quickly be gathered with non-invasive testing. We hope to understand more of the underlying mechanisms of migraine by studying reaction time in migraine patients.
Read more
Our previous pilot study, with less stringent inclusion and exclusion criteria, looked at fewer patients (32 migraineurs and 32 controls), and found that migraineurs showed significantly different saccadic patterns to non-migraineurs.
This study firstly seeks to corroborate the saccadometric findings of our earlier pilot study in a group of migraineurs, and secondly to explore the specificity of these findings in migraine by also studying patients with another primary headache syndrome, namely cluster headache.
Migraine is known to be a dynamic disorder, with previous studies showing longitudinal changes in the migraine brain. To explore this further we hope to record longitudinally (Every day for 21 days) in a small subset of migraineurs to identify potential longitudinal changes in saccadic reaction time. Because of the portability of the equipment this could be done in the subjects own home if they preferred.
Read the detailed description
As above
- Conditions
- Migraine, Cluster Headache, Control, Menstrual Migraine
- Medical subject headings
- Migraine Disorders, Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Episodic Migraine. | Not described | |
| menstrual migraine | Not described | |
| Cluster Headache patients | Not described | |
| control (non-headache group) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To see if Saccadometry results differ between controls and migraine subjects
Measured: By May 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startAug 2011
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
Why it stopped: Lack of available clinical time to complete
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tim Young
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tim Young, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395264
- Sponsor's protocol ID
- 10/0366
- Status last verified
- Oct 2017
- First submitted
- 14 Jul 2011
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saccadometry in Primary Headache Syndromes
- ClinicalTrials.gov ID
- NCT01395264
- Acronym / sponsor ID
- 10/0366
- Conditions
- Migraine, Cluster Headache, Control, Menstrual Migraine
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of available clinical time to complete
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Tim YoungUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 15 Jul 2011 (estimated)
- 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.
Migraine is one of the commonest neurological disorders, affecting up to 12% of the general population, but remains relatively under-diagnosed and under-treated. Migraine has a wide socioeconomic impact and brings a large economic burden; estimates suggest that disability due to migraine costs > €27 billion per annum across Europe. Despite its prevalence and impact, migraine pathophysiology is poorly understood. A wider understanding of the functional changes in this disorder would be beneficial to both diagnosis and treatment.
Saccades are the rapid eye movements we make when moving the eyes to a new object in our visual field. Reaction time studies have been used to investigate Huntington's disease and Parkinson's disease with great success. These use saccadic tasks (monitoring eye movements). Even at rest we make approximately three saccades per second, so a lot of data can quickly be gathered with non-invasive testing. We hope to understand more of the underlying mechanisms of migraine by studying reaction time in migraine patients.
Our previous pilot study, with less stringent inclusion and exclusion criteria, looked at fewer patients (32 migraineurs and 32 controls), and found that migraineurs showed significantly different saccadic patterns to non-migraineurs.
This study firstly seeks to corroborate the saccadometric findings of our earlier pilot study in a group of migraineurs, and secondly to explore the specificity of these findings in migraine by also studying patients with another primary headache syndrome, namely cluster headache.
Migraine is known to be a dynamic disorder, with previous studies showing longitudinal changes in the migraine brain. To explore this further we hope to record longitudinally (Every day for 21 days) in a small subset of migraineurs to identify potential longitudinal changes in saccadic reaction time. Because of the portability of the equipment this could be done in the subjects own home if they preferred.
Detailed description
As above
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Episodic Migraine. | – | – |
| menstrual migraine | – | – |
| Cluster Headache patients | – | – |
| control (non-headache group) | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- From hospital Headache clinics (secondary and tertiary)
Key inclusion criteria (4 listed)
- Male or female and aged between 18 and 60 years in good general health apart from suffering from headaches (test group).
- Migraine and cluster headache will be diagnosed according to ICHD-II diagnostic criteria (6).
- Migraineurs must suffer at least two migraine attacks per year and no more than 5 attacks per month.
- -
Key exclusion criteria (5 listed)
- Any other neurological disorder such as stroke, multiple sclerosis, epilepsy, concussion within the past year, psychiatric disorders, visual disorders.
- Use of migraine prophylactic medication in the last month or acute migraine therapy in the 3 days prior to testing.
- Patients on any medication to treat depression in their case
- Headache during testing or within 3 days before and after testing.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To see if Saccadometry results differ between controls and migraine subjects
Time frame: By May 2019
Results and safety
The study was stopped early (reason given: Lack of available clinical time to complete). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Cluster Headache, run by Tim Young at 2 sites in United Kingdom.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 was stopped early (reason given: Lack of available clinical time to complete). Results are not available in the source record.
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?
To see if Saccadometry results differ between controls and migraine subjects (time frame: By May 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2017.