Condition category
Nervous System Diseases
Date applied
02/05/2007
Date assigned
02/05/2007
Last edited
02/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.lumc.nl/

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

Publication citations

Additional files

Editorial Notes