Trigeminal Brainstem Mapping

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Electric Current Stimulation

About this trial

This is an interventional basic science trial for Headache Disorders, Primary

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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