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Saccadometry in Primary Headache Syndromes

NCT ID: NCT01395264

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2017-10-27

Brief Summary

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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

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As above

Conditions

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Migraine Cluster Headache Control Menstrual Migraine

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Episodic Migraine.

No interventions assigned to this group

menstrual migraine

No interventions assigned to this group

Cluster Headache patients

No interventions assigned to this group

control (non-headache group)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Male or female and aged between 18 and 60 years in good general health apart from suffering from headaches (test group).
2. Migraine and cluster headache will be diagnosed according to ICHD-II diagnostic criteria (6).
3. Migraineurs must suffer at least two migraine attacks per year and no more than 5 attacks per month.

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Exclusion Criteria

1. Any other neurological disorder such as stroke, multiple sclerosis, epilepsy, concussion within the past year, psychiatric disorders, visual disorders.
2. Use of migraine prophylactic medication in the last month or acute migraine therapy in the 3 days prior to testing.
3. Patients on any medication to treat depression in their case
4. Headache during testing or within 3 days before and after testing.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tim Young

OTHER

Sponsor Role lead

Responsible Party

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Tim Young

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Neurology Department, Whittington Hospital

London, , United Kingdom

Site Status

The National Hospital for Neurology and Neurosurgery, London WC1N 3BG, and The John Radcliffe hospital, Oxford, The Whittington Hospital N19 5NF London

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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10/0366

Identifier Type: -

Identifier Source: org_study_id