Subclinical cerebellar dysfunction in patients with migraine

ISRCTN	ISRCTN94004433
DOI	https://doi.org/10.1186/ISRCTN94004433
Secondary identifying numbers	NL914 (NTR938)

Submission date: 02/05/2007
Registration date: 02/05/2007
Last edited: 22/09/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr W. Brekelmans
Scientific

Leiden University Medical Centre (LUMC)
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 526 1730
Email	w.brekelmans@umail.leidenuniv.nl

Study information

Study design	Observational, parallel group, case-control study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Subclinical cerebellar dysfunction in patients with migraine
Study objectives	Migraine patients, compared with healthy volunteers, have more subclinical cerebellar dysfunctions, measured by the eye-blinker.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/03/2007
Completion date	10/06/2007

Eligibility

Participant type(s)	Healthy volunteer
Age group	Not Specified
Sex	Not Specified
Target number of participants	60
Key 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
Key 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
Date of first enrolment	01/03/2007
Date of final enrolment	10/06/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Centre (LUMC)

Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Centre (LUMC) (The Netherlands)
Hospital/treatment centre

Department of Neurology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Website	http://www.lumc.nl/
"ROR"	https://ror.org/027bh9e22

Funders

Funder type

Hospital/treatment centre

Leiden University Medical Centre (LUMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

22/09/2021: Proactive update review. No publications found. Search options exhausted.