|- candidate number||2514|
|- NTR Number||NTR938|
|- Date ISRCTN created||2-mei-2007|
|- date ISRCTN requested||20-apr-2007|
|- Date Registered NTR||12-mrt-2007|
|- Secondary IDs||N/A |
|- Public Title||Subclinical cerebellar dysfunction in patients with migraine.|
|- Scientific Title||Subclinical cerebellar dysfunction in patients with migraine.|
|- hypothesis||Migraine patients, compared with healthy volunteers, have more subclinical cerebellar dysfunctions, measured by the eye-blinker.|
|- Healt Condition(s) or Problem(s) studied||Migraine, Eyeblink, Cerebellum, Sway test|
|- Inclusion criteria||1. Patients with migraine and aura with minimal 6 attacks a year (2 with aura);|
2. Healthy volunteers without migraine;
3. Patients with a cerebellar degenerative diseases.
|- Exclusion criteria||For the migrainepatients and healthy controls: |
1. Neurologic 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.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-mrt-2007|
|- planned closingdate||10-jun-2007|
|- Target number of participants||60|
|- Interventions||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 8 trials of 6 minutes. A conditioned respons will be generated by using airpuffs and tones.|
|- Primary outcome||The conditioning as measured with eyeblink between migrainepatients and controls.
|- Secondary outcome||1. The sensitivity of trigeminus system by migrainepatients compared with controls.
Do the results of the disturbed conditioned corresponds to a coordinationdisorder measured by the sway-test?;|
2. The relations between the contols, the migrainepatients and the patients with a degenerative disease.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| W. Brekelmans|
|- CONTACT for SCIENTIFIC QUERIES|| W. Brekelmans|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Neurology |
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC), Department of Neurology|
|- Brief summary||Earlier examinations possibly shows small damage of the cerebellum in patients with migraine, especially in patients with aura. These defects are structural as well as functional. It is also shown that conditioning largely takes place in the cerebellum. The eye-blinker is a valid method to measure conditioning. The Sway-test is a good methode to measure the coordination and to detect minimal movements. |
This study will examine the difference in conditioning between patients with migraine en healthy volunteers.
|- Main changes (audit trail)|
|- RECORD||12-mrt-2007 - 1-dec-2009|