Contact information
Type
Scientific
Primary contact
Dr W. Brekelmans
ORCID ID
Contact details
Leiden University Medical Centre (LUMC)
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 1730
w.brekelmans@umail.leidenuniv.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Migraine patients, compared with healthy volunteers, have more subclinical cerebellar dysfunctions, measured by the eye-blinker.
Ethics approval
Not provided at time of registration
Study design
Observational, parallel group, case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Migraine with aura
Intervention
The difference in the conditioning, between migraineurs and healthy volunteers, is measured by using the eyeblinker. The technique is called the chip-MDMT (Magnetic Distant Measurement Technique). A magnet will be placed on the right eyelid. A sensor will be placed below the right eye. So the length, the power and the time of each blink is measured. The test will consist of eight trials of six minutes. A conditioned response will be generated by using airpuffs and tones.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The conditioning as measured with eyeblink between migraine patients and controls.
Secondary outcome measures
1. The sensitivity of the trigeminus system by migraine patients compared with controls: do the results of the disturbed conditioned corresponds to a coordination disorder measured by the sway-test?
2. The relations between the controls, the migraine patients and the patients with a degenerative disease
Overall trial start date
01/03/2007
Overall trial end date
10/06/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with migraine and aura with minimal six attacks a year (two with aura)
2. Healthy volunteers without migraine
3. Patients with a cerebellar degenerative disease
Participant type
Healthy volunteer
Age group
Not Specified
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
For the migraine patients and healthy controls:
1. Neurological diseases in which the function of cerebellum is disturbed
2. The use of medicines/drugs which have influence on the coordination 24 hours before taking part of this examination
Recruitment start date
01/03/2007
Recruitment end date
10/06/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (LUMC) (The Netherlands)
Sponsor details
Department of Neurology
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leiden University Medical Centre (LUMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary