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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06535880
Enrollment
40
Registered
2024-08-02
Start date
2024-08-01
Completion date
2027-12-31
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Disorders

Brief summary

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.

Detailed description

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

Interventions

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

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy * suitable fo MRI

Exclusion criteria

* headache disease * psychological disorder * pregnancy * all

Design outcomes

Primary

MeasureTime frameDescription
Statistical Parametric Maps calculated from the fMRI data on brainstem levelonly 1 visitAt 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.
Statistical Parametric Maps calculated from the fMRI data of higher cortical brain structuresonly 1 visitAnterior and posterior insula, the cingulate cortex and S1/S2 will show significant activation at an small-volume corrected threshold of p\<0.05

Secondary

MeasureTime frameDescription
Functional connectivty between insula and spinal trigeminal cortexonly 1 visitFor 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026