Migraine Without AuraNCT00263991
Cortical Reorganisation in Patients With Primary Headache Disorders
An observational study of Migraine Without Aura and Chronic Tension-Type Headache, run by Danish Headache Center at 1 site in Denmark.
Trial summary
Primary headache disorders are now accepted as physiological diseases, and advanced imaging-techniques have demonstrated a migraine generator in the brain stem and increased stimulus sensitivity in these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Without Aura, Chronic Tension-Type Headache
- What is being tested?
- EEC-techniques
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis og migraine without aura or chronic tension-type headache
Who cannot join
- serious somatic or psychiatric diseases including depression
- overuse of analgesics
- regular intake of opiates or benzodiazepines
- intake of prophylactic headache medication
- pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center; Department of Neurology, Glostrup Hospital, University of Copenhagen
Glostrup, Copenhagen, 2600
About this study
Primary headache disorders are now accepted as physiological diseases, and advanced imaging-techniques have demonstrated a migraine generator in the brain stem and increased stimulus sensitivity in these patients. The underlying neuronal dysfunctions remain to to clarified and the existing neurophysiological methods have not yet been useful. More sensitive and reliable methods are therefore highly needed. The aims of the study are therefore to develop a sensitive and reliable method to demonstrate a cortical reorganisation and expansion of pain sensitive cortical areas in patients with migraine or tension-type headache.
- Being tested
- EEC-techniques
- Medical subject headings
- Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEC-techniquesDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine Without AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Investigators
- Lars Bendtsen, MD, Ph.d, Principal investigator, Danish Headache Center, Department of Neurology, Glostrup Hospital, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263991
- Sponsor's protocol ID
- KA 05085
- Status last verified
- Aug 2005
- First submitted
- 9 Dec 2005
- Last updated
- 12 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Reorganisation in Patients With Primary Headache Disorders
- ClinicalTrials.gov ID
- NCT00263991
- Acronym / sponsor ID
- KA 05085
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- First posted
- 12 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary headache disorders are now accepted as physiological diseases, and advanced imaging-techniques have demonstrated a migraine generator in the brain stem and increased stimulus sensitivity in these patients. The underlying neuronal dysfunctions remain to to clarified and the existing neurophysiological methods have not yet been useful. More sensitive and reliable methods are therefore highly needed. The aims of the study are therefore to develop a sensitive and reliable method to demonstrate a cortical reorganisation and expansion of pain sensitive cortical areas in patients with migraine or tension-type headache.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis og migraine without aura or chronic tension-type headache
Key exclusion criteria (5 listed)
- serious somatic or psychiatric diseases including depression
- overuse of analgesics
- regular intake of opiates or benzodiazepines
- intake of prophylactic headache medication
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEC-techniques | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Bendtsen, MD, Ph.d principal investigator
Danish Headache Center, Department of Neurology, Glostrup Hospital, University of Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Without Aura and Chronic Tension-Type Headache, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2005.