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

Not Applicable

Recruiting

• Conditions: Migraine Disorders
• Interventions: Device: Electric Current Stimulation

• Registration Number: NCT06535880
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

In previous studies we showed clustering of the three branches of the trigeminal nerve in brainstem, 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, we aim 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)

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-07-30
• Last Update Submitted: 2024-07-30
• Study Start: 2024-08-01
• Study First Posted: 2024-08-02
• Last Update Posted: 2024-08-02
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Statistical Parametric Maps calculated from the fMRI data on brainstem level	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.
Statistical Parametric Maps calculated from the fMRI data of higher cortical brain structures	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 Outcome Measures

Name	Time	Method
Functional connectivty between insula and spinal trigeminal cortex	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.

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany