Saccadometry in Primary Headache Syndromes

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.

Study Overview

• Status: Terminated
• Conditions: Migraine; Cluster Headache; Control; Menstrual Migraine

Detailed Description

As above

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

From hospital Headache clinics (secondary and tertiary)

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Episodic Migraine.
menstrual migraine
Cluster Headache patients
control (non-headache group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To see if Saccadometry results differ between controls and migraine subjects	By May 2019

Collaborators and Investigators

• Sponsor: Tim Young

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 27, 2017
• Study Completion (Actual): October 27, 2017

Study Registration Dates

• First Submitted: July 14, 2011
• First Submitted That Met QC Criteria: July 14, 2011
• First Posted (Estimate): July 15, 2011

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 27, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Trigeminal Autonomic Cephalalgias; Migraine Disorders; Headache; Headache Disorders; Cluster Headache
• Other Study ID Numbers: 10/0366