Trigeminal Brainstem Mapping

Not Applicable

Completed

• Conditions: Migraine; Headache Disorders, Primary
• Interventions: Device: Electric Current Stimulation

• Registration Number: NCT03999060
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-26
• Study Start: 2019-06-28
• Primary Completion: 2019-09-27
• Study Completion: 2019-09-27
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-06
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electric Stimulation	Electric Current Stimulation	-

Primary Outcome Measures

Name	Time	Method
Statistical Parametric Map calculated from the fMRI data in the insula	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)
Statistical Parametric Map calculated from the fMRI data in the thalamus	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 on brainstem level	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)

Secondary Outcome Measures

Name	Time	Method
Statistical Parametric Map calculated from the fMRI data in the cerebellum	through study completion, an average of 9 months
Statistical Parametric Map calculated from the fMRI data in the periaqueductal gray (PAG)	through study completion, an average of 9 months

Trial Locations

Locations (1)

UKE; 🇩🇪 Hamburg, Germany