Headache Disorders, PrimaryNCT03999060
Trigeminal Brainstem Mapping
A study testing Electric Current Stimulation in people with Headache Disorders, Primary and Migraine, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
To what extent the somatotopy of the 3 branches of the trigeminal nerve (V1,V2,V3) as well as the greater occipital nerve (GON) in the brainstem but also in the thalamus and the insula can be mapped using functional imaging and BOLD in humans is not known but might play an important role in imaging headache diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache Disorders, Primary, Migraine
- What is being tested?
- Electric Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jun 2019to 27 Sep 2019
- Phase
- Interventional
- 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
- healthy
- suitable fo MRI
Who cannot join
- headache disease
- psychological disorder
- pregnancy
- all exclusion criteria necessary for imaging in a 3 T MRI scanner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brainstem Mapping of Nociceptive Trigeminal Input
To what extent the somatotopy of the 3 branches of the trigeminal nerve (V1,V2,V3) as well as the greater occipital nerve (GON) in the brainstem but also in the thalamus and the insula can be mapped using functional imaging and BOLD in humans is not known but might play an important role in imaging headache diseases. The aim is to map their somatotopy by random stimulation of V1, V2, V3 and the GON with painful electrical input during acquisition of BOLD-fMRI.
- Conditions
- Headache Disorders, Primary, Migraine
- Being tested
- Electric Current Stimulation
- Medical subject headings
- Headache Disorders, Primary, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric Current StimulationDevice
Electric stimulation with a Digitimer DS7AH HV Current Stimulator delivered with 4 shielded electrodes mounted on the participants head
| Study group | Role | What they receive |
|---|---|---|
| Electric Stimulation | Experimental | Not described Receives: Device: Electric Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistical Parametric Map calculated from the fMRI data on brainstem level
At a statistical threshold of T-value 3 we will observe a somatotopical arrangement in the brainstem below the pons:
Expected location for V1: within radius of 10 mm around the MNI coordinates (-1,-48,-75); Expected location for V2: within radius of 10 mm around the MNI coordinates (-4,-47,-69) Expected location for V3: within radius of 10 mm around the MNI coordinates (-1,-46,-66) Expected location for GON: within radius of 10 mm around the MNI coordinates (-1,-45,-64)
Measured: through study completion, an average of 9 months
Statistical Parametric Map calculated from the fMRI data in the thalamus
At a statistical threshold of T-value 4 we will observe a somatotopical arrangement in the thalamus:
Expected location for V1: within radius of 10 mm around the MNI coordinates (11,-5,6); Expected location for V2: within radius of 10 mm around the MNI coordinates (13,-11,5) Expected location for V3: within radius of 10 mm around the MNI coordinates (12,-10,5) Expected location for GON: within radius of 10 mm around the MNI coordinates (15,-12,-7)
Measured: through study completion, an average of 9 months
Statistical Parametric Map calculated from the fMRI data in the insula
At a statistical threshold of T-value 4 we will observe a somatotopical arrangement in the insula:
Expected location for V1: within radius of 10 mm around the MNI coordinates (38,-15,8); Expected location for V2: within radius of 10 mm around the MNI coordinates (37,-8,-5) Expected location for V3: within radius of 10 mm around the MNI coordinates (39,2,-11) Expected location for GON: within radius of 10 mm around the MNI coordinates (38,-12,-3)
Measured: through study completion, an average of 9 months
Secondary outcomes (2)
Statistical Parametric Map calculated from the fMRI data in the cerebellum
Measured: through study completion, an average of 9 months
Statistical Parametric Map calculated from the fMRI data in the periaqueductal gray (PAG)
Measured: through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start28 Jun 2019
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Headache Disorders, PrimaryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arne May, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999060
- Sponsor's protocol ID
- TrigeminalBrainstemMapping
- Status last verified
- Oct 2019
- First submitted
- 13 Jun 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Group results will be presented at international conferences as well as published in international peer-reviewed journals
Publications
Mehnert J, Basedau H, Sturm LM, Nielsen T, Jensen RH, May A. Functional brainstem representations of the human trigeminal cervical complex. Cephalalgia. 2023 May;43(5):3331024231174862. doi: 10.1177/03331024231174862.
PubMed 37203351
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brainstem Mapping of Nociceptive Trigeminal Input
- ClinicalTrials.gov ID
- NCT03999060
- Acronym / sponsor ID
- TrigeminalBrainstemMapping
- Conditions
- Headache Disorders, Primary, Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 26 Jun 2019 (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.
To what extent the somatotopy of the 3 branches of the trigeminal nerve (V1,V2,V3) as well as the greater occipital nerve (GON) in the brainstem but also in the thalamus and the insula can be mapped using functional imaging and BOLD in humans is not known but might play an important role in imaging headache diseases. The aim is to map their somatotopy by random stimulation of V1, V2, V3 and the GON with painful electrical input during acquisition of BOLD-fMRI.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electric Stimulation | Experimental | Device: Electric Current Stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy
- suitable fo MRI
Key exclusion criteria (4 listed)
- headache disease
- psychological disorder
- pregnancy
- all exclusion criteria necessary for imaging in a 3 T MRI scanner
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 |
|---|---|---|
| Electric Current StimulationElectric stimulation with a Digitimer DS7AH HV Current Stimulator delivered with 4 shielded electrodes mounted on the participants head | Device | Electric Stimulation |
Primary outcome
Statistical Parametric Map calculated from the fMRI data on brainstem level
Time frame: through study completion, an average of 9 months
At a statistical threshold of T-value 3 we will observe a somatotopical arrangement in the brainstem below the pons: Expected location for V1: within radius of 10 mm around the MNI coordinates (-1,-48,-75); Expected location for V2: within radius of 10 mm around the MNI coordinates (-4,-47,-69) Expected location for V3: within radius of 10 mm around the MNI coordinates (-1,-46,-66) Expected location for GON: within radius of 10 mm around the MNI coordinates (-1,-45,-64)
Statistical Parametric Map calculated from the fMRI data in the thalamus
Time frame: through study completion, an average of 9 months
At a statistical threshold of T-value 4 we will observe a somatotopical arrangement in the thalamus: Expected location for V1: within radius of 10 mm around the MNI coordinates (11,-5,6); Expected location for V2: within radius of 10 mm around the MNI coordinates (13,-11,5) Expected location for V3: within radius of 10 mm around the MNI coordinates (12,-10,5) Expected location for GON: within radius of 10 mm around the MNI coordinates (15,-12,-7)
Statistical Parametric Map calculated from the fMRI data in the insula
Time frame: through study completion, an average of 9 months
At a statistical threshold of T-value 4 we will observe a somatotopical arrangement in the insula: Expected location for V1: within radius of 10 mm around the MNI coordinates (38,-15,8); Expected location for V2: within radius of 10 mm around the MNI coordinates (37,-8,-5) Expected location for V3: within radius of 10 mm around the MNI coordinates (39,2,-11) Expected location for GON: within radius of 10 mm around the MNI coordinates (38,-12,-3)
2 secondary outcomes
Statistical Parametric Map calculated from the fMRI data in the cerebellum
Time frame: through study completion, an average of 9 months
Statistical Parametric Map calculated from the fMRI data in the periaqueductal gray (PAG)
Time frame: through study completion, an average of 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Derived from this study: PubMed 37203351Mehnert J, Basedau H, Sturm LM, Nielsen T, Jensen RH, May A. Functional brainstem representations of the human trigeminal cervical complex. Cephalalgia. 2023 May;43(5):3331024231174862. doi: 10.1177/03331024231174862.
- Individual participant dataSharing planned: No. Group results will be presented at international conferences as well as published in international peer-reviewed journals
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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.
Arne May, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric Current Stimulation in people with Headache Disorders, Primary and Migraine, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 8 Oct 2019. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Statistical Parametric Map calculated from the fMRI data on brainstem level (time frame: through study completion, an average of 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03999060, which also lists 1 linked publication.
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 8 Oct 2019.