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Trigeminal Brainstem Mapping

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ClinicalTrials.gov Identifier: NCT03999060
Recruitment Status : Completed
First Posted : June 26, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Headache Disorders, Primary Migraine Device: Electric Current Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Brainstem Mapping of Nociceptive Trigeminal Input
Actual Study Start Date : June 28, 2019
Actual Primary Completion Date : September 27, 2019
Actual Study Completion Date : September 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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




Primary Outcome Measures :
  1. 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)


  2. 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)


  3. 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)



Secondary Outcome Measures :
  1. Statistical Parametric Map calculated from the fMRI data in the cerebellum [ Time Frame: through study completion, an average of 9 months ]
  2. Statistical Parametric Map calculated from the fMRI data in the periaqueductal gray (PAG) [ Time Frame: through study completion, an average of 9 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03999060


Locations
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Germany
UKE
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Arne May, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03999060     History of Changes
Other Study ID Numbers: TrigeminalBrainstemMapping
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Group results will be presented at international conferences as well as published in international peer-reviewed journals

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Headache Disorders
Headache Disorders, Primary
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases