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Completed

NCT Number: NCT03999060

Trigeminal Brainstem Mapping

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.

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Key information

Conditions

Headache Disorders, Primary Brain Diseases Central Nervous System Diseases Headache Disorders Migraine Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UKE

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electric Current Stimulation

Device

Electric stimulation with a Digitimer DS7AH HV Current Stimulator delivered with 4 shielded electrodes mounted on the participants head

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Brainstem Mapping of Nociceptive Trigeminal Input

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2019
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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