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NCT Number: NCT06535880

Trigeminal Brainstem Mapping 2: Higher Cortical Strucureas as Well as Subnuclei of the Spinal Trigeminal Nucleus

In previous studies clustering of the three branches of the trigeminal nerve in brainstem were shown, cerebellum and periaqueductal gray. To further evaluate higher cortical structures, which were not covered by our previous field of view (FOV) and to further investigate the identified 'subnuclei' of the spinal trigeminal nucleus, here the aim is to scan the whole brain as well as the brainstem and the upper spinal cord during trigeminal nociceptive as well as non-nociceptive electrical stimulation of all three branches of the trigeminal nerve (and the arm as a somatic control site) during acquisition of BOLD-fMRI in humans.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

Preprocessing and processing of the MR data will follow our previous publications (Mehnert et al 2023, Mehnert et al 2024)

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 and arm

Primary outcomes

  1. Statistical Parametric Maps calculated from the fMRI data on brainstem level

    Time frame: only 1 visit

    At an small volume corrected threshold of p<0.05 will be reproduce activation of all previously shown subnuclei of the spinal trigeminal nucleus for all three trigeminal branches using a sphere of 10 mm around previously published (Mehnert et al, 2023) MNI coordinates.

  2. Statistical Parametric Maps calculated from the fMRI data of higher cortical brain structures

    Time frame: only 1 visit

    Anterior and posterior insula, the cingulate cortex and S1/S2 will show significant activation at an small-volume corrected threshold of p<0.05

Secondary outcomes

  1. Functional connectivty between insula and spinal trigeminal cortex

    Time frame: only 1 visit

    For each of the trigeminal subnuclei we will calculate the functional connectivity to higher cortical areas, such as the anterior and posterior insula, the cingulate cortex and S1/S2 with a psycho-physiological interaction analysis (PPI) for painful as well as non-painful stimulation to characterize the function of each subnucleus.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Brainstem Mapping of Nociceptive and Non-nociceptive Trigeminal Input and Its Functional Connectivty

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 2, 2024
Registry last updated
May 18, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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