An interventional study of Electric Current Stimulation in Headache Disorders, Primary and Migraine, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-08.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Basic science
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 36 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.
Compared within Migraine Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Headache Disorders, Primary. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Device: Electric Current Stimulation
Electric stimulation with a Digitimer DS7AH HV Current Stimulator delivered with 4 shielded electrodes mounted on the participants head
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)
Time frame: 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)
Time frame: 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)
Time frame: through study completion, an average of 9 months
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
Plan to share: No — Group results will be presented at international conferences as well as published in international peer-reviewed journals
No publications or documents are linked to this record.
Ran from Jun 2019 to primary completion in Sep 2019, 2 months.
Of 309 non-industry interventional studies with no phase under Migraine Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 2 months is below that.
Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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