HeadacheNCT03269539
Assessment of Siemens' GoBrain and DotBrain Software
An observational study of Headache, run by University of Saskatchewan.
Trial summary
Our main approach in this research is to collect MR data using both a "Routine" and "Fast" brain protocol on the 3 Tesla Siemens Skyra scanner using a 20-Channel Head/Neck Coil to determine if the "Fast" protocol can collect data in less time without compromising patient care. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Headache
- What is being tested?
- MRI Imaging
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to May 2018
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients referred for MRI with History of Headaches
Who may be able to join
- Patients referred for MRI with History of Headaches
Who cannot join
- Patient does not meet MRI safety criteria
- Patient has known Brain Pathology
About this study
Our main approach in this research is to collect MR data using both a "Routine" and "Fast" brain protocol on the 3 Tesla Siemens Skyra scanner using a 20-Channel Head/Neck Coil to determine if the "Fast" protocol can collect data in less time without compromising patient care.
- Conditions
- Headache
- Being tested
- MRI Imaging
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ImagingOther
| Study group | Role | What they receive |
|---|---|---|
| Headache Patients | Patients Referred for MRI with History of Headaches Receives: Other: MRI Imaging | |
| Motion prone patients | Patients without the ability to remain still for the entire protocol Receives: Other: MRI Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Siemens' GoBrain and DotBrain Software
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study startNov 2016
- Primary completionNov 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269539
- Sponsor's protocol ID
- Bio 16-278
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Siemens' GoBrain and DotBrain Software
- ClinicalTrials.gov ID
- NCT03269539
- Acronym / sponsor ID
- Bio 16-278
- Conditions
- Headache
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 31 Aug 2017 (actual)
- 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.
Our main approach in this research is to collect MR data using both a "Routine" and "Fast" brain protocol on the 3 Tesla Siemens Skyra scanner using a 20-Channel Head/Neck Coil to determine if the "Fast" protocol can collect data in less time without compromising patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Headache Patients | – | Other: MRI ImagingPatients Referred for MRI with History of Headaches |
| Motion prone patients | – | Other: MRI ImagingPatients without the ability to remain still for the entire protocol |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred for MRI with History of Headaches
Key inclusion criteria (1 listed)
- Patients referred for MRI with History of Headaches
Key exclusion criteria (2 listed)
- Patient does not meet MRI safety criteria
- Patient has known Brain Pathology
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 |
|---|---|---|
| MRI Imaging | Other | Headache Patients, Motion prone patients |
Primary outcome
Assessment of Siemens' GoBrain and DotBrain Software
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, run by University of Saskatchewan.
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 2 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 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Assessment of Siemens' GoBrain and DotBrain Software (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 31 Aug 2017.