Trigeminal Brainstem Mapping

October 6, 2019 updated by: Universitätsklinikum Hamburg-Eppendorf

Brainstem Mapping of Nociceptive Trigeminal Input

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • UKE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Electric Stimulation
Device: Electric Current Stimulation
Electric stimulation with a Digitimer DS7AH HV Current Stimulator delivered with 4 shielded electrodes mounted on the participants head

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Statistical Parametric Map calculated from the fMRI data on brainstem level
Time Frame: 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)
through study completion, an average of 9 months
Statistical Parametric Map calculated from the fMRI data in the thalamus
Time Frame: 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)
through study completion, an average of 9 months
Statistical Parametric Map calculated from the fMRI data in the insula
Time Frame: 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)
through study completion, an average of 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Statistical Parametric Map calculated from the fMRI data in the cerebellum
Time Frame: through study completion, an average of 9 months
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
through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Arne May, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 28, 2019

Primary Completion (ACTUAL)

September 27, 2019

Study Completion (ACTUAL)

September 27, 2019

Study Registration Dates

First Submitted

June 13, 2019

First Submitted That Met QC Criteria

June 25, 2019

First Posted (ACTUAL)

June 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2019

Last Update Submitted That Met QC Criteria

October 6, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TrigeminalBrainstemMapping

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Group results will be presented at international conferences as well as published in international peer-reviewed journals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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