Trigeminal Brainstem Mapping
Primary Purpose
Headache Disorders, Primary, Migraine
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Electric Current Stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Headache Disorders, Primary
Eligibility Criteria
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
Sites / Locations
- UKE
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Electric Stimulation
Arm Description
Outcomes
Primary Outcome Measures
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)
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)
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)
Secondary Outcome Measures
Statistical Parametric Map calculated from the fMRI data in the cerebellum
Statistical Parametric Map calculated from the fMRI data in the periaqueductal gray (PAG)
Full Information
NCT ID
NCT03999060
First Posted
June 13, 2019
Last Updated
October 6, 2019
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT03999060
Brief Title
Trigeminal Brainstem Mapping
Official Title
Brainstem Mapping of Nociceptive Trigeminal Input
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 28, 2019 (Actual)
Primary Completion Date
September 27, 2019 (Actual)
Study Completion Date
September 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache Disorders, Primary, Migraine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electric Stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Electric Current Stimulation
Intervention Description
Electric stimulation with a Digitimer DS7AH HV Current Stimulator delivered with 4 shielded electrodes mounted on the participants head
Primary Outcome Measure Information:
Title
Statistical Parametric Map calculated from the fMRI data on brainstem level
Description
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
Title
Statistical Parametric Map calculated from the fMRI data in the thalamus
Description
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
Title
Statistical Parametric Map calculated from the fMRI data in the insula
Description
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
Secondary Outcome Measure Information:
Title
Statistical Parametric Map calculated from the fMRI data in the cerebellum
Time Frame
through study completion, an average of 9 months
Title
Statistical Parametric Map calculated from the fMRI data in the periaqueductal gray (PAG)
Time Frame
through study completion, an average of 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne May, Prof. Dr.
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
UKE
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Group results will be presented at international conferences as well as published in international peer-reviewed journals
Learn more about this trial
Trigeminal Brainstem Mapping
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