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Saccadometry in Primary Headache Syndromes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by University College London Hospitals.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01395264
First Posted: July 15, 2011
Last Update Posted: July 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University College London Hospitals
  Purpose

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.


Condition
Migraine Cluster Headache Control Menstrual Migraine

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Saccadometry in Primary Headache Syndromes

Resource links provided by NLM:


Further study details as provided by University College London Hospitals:

Estimated Enrollment: 162
Study Start Date: August 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Episodic Migraine.
menstrual migraine
Cluster Headache patients
control (non-headache group)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
From hospital Headache clinics (secondary and tertiary)
Criteria

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.

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395264


Contacts
Contact: Manjit Matharu, BSc MBChB MRCP PhD 08451555000 Ext 723664 m.matharu@uclmail.net

Locations
United Kingdom
The National Hospital for Neurology and Neurosurgery, London WC1N 3BG, and The John Radcliffe hospital, Oxford, The Whittington Hospital N19 5NF London Not yet recruiting
London, United Kingdom, WC1N 3BG
Contact: Tim Young, BSc MBBS MRCP PhD         
Sponsors and Collaborators
University College London Hospitals
  More Information

Responsible Party: Dr Manjit Matharu, Senior Lecturer and Honorary Consultant Neurologist, The National Hospital for Neurology & Neurosurgery, University College London Hospital
ClinicalTrials.gov Identifier: NCT01395264     History of Changes
Other Study ID Numbers: 10/0366
First Submitted: July 14, 2011
First Posted: July 15, 2011
Last Update Posted: July 15, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Headache Disorders
Headache Disorders, Primary
Migraine Disorders
Headache
Cluster Headache
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Autonomic Cephalalgias