Trigeminal Brainstem Mapping

Migraine Clinical Trial

Official title:

Brainstem Mapping of Nociceptive Trigeminal Input

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03999060
• Other study ID #: TrigeminalBrainstemMapping
• Status: Completed
• Phase: N/A
• Start date: June 28, 2019
• Est. completion date: September 27, 2019

Study information

• Verified date: October 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 27, 2019
• Est. primary completion date: September 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• healthy

• suitable fo MRI

Exclusion Criteria:

• headache disease

• psychological disorder

• pregnancy

• all exclusion criteria necessary for imaging in a 3 T MRI scanner

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Headache Disorders, Primary
• Migraine

Intervention

Device:
• Electric Current Stimulation
Electric stimulation with a Digitimer DS7AH HV Current Stimulator delivered with 4 shielded electrodes mounted on the participants head

Locations

Country	Name	City	State
Germany	UKE	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	through study completion, an average of 9 months
Primary	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)	through study completion, an average of 9 months
Primary	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)	through study completion, an average of 9 months
Secondary	Statistical Parametric Map calculated from the fMRI data in the cerebellum		through study completion, an average of 9 months
Secondary	Statistical Parametric Map calculated from the fMRI data in the periaqueductal gray (PAG)		through study completion, an average of 9 months