Subclinical cerebellar dysfunction in patients with migraine
| ISRCTN | ISRCTN94004433 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94004433 |
| Protocol serial number | NL914 (NTR938) |
| Sponsor | Leiden University Medical Centre (LUMC) (The Netherlands) |
| Funder | Leiden University Medical Centre (LUMC) (The Netherlands) |
- 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
Scientific
Leiden University Medical Centre (LUMC)
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 1730 |
|---|---|
| w.brekelmans@umail.leidenuniv.nl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational, parallel group, case-control study |
| Secondary study design | Case-control study |
| 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(s) |
The conditioning as measured with eyeblink between migraine patients and controls. |
| Key secondary outcome measure(s) |
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? |
| Completion date | 10/06/2007 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
22/09/2021: Proactive update review. No publications found. Search options exhausted.
