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

NCT06535880 | Recruiting

• 1 other identifier: TrigeminalBrainstemMapping2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (2)

• Statistical Parametric Maps calculated from the fMRI data on brainstem level

  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.

  only 1 visit

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

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

  only 1 visit

Secondary Outcomes (1)

• Functional connectivty between insula and spinal trigeminal cortex

  only 1 visit

Study Arms (1)

Electric Stimulation

EXPERIMENTAL

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

Device: Electric Current Stimulation

Interventions

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

Electric Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy
• suitable fo MRI

You may not qualify if:

• headache disease
• psychological disorder
• pregnancy

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Related Publications (3)

• Mehnert J, Basedau H, Sturm LM, Nielsen T, Jensen RH, May A. Functional brainstem representations of the human trigeminal cervical complex. Cephalalgia. 2023 May;43(5):3331024231174862. doi: 10.1177/03331024231174862.

  PMID: 37203351 BACKGROUND

• Basedau H, May A, Mehnert J. Cerebellar somatotopy of the trigemino-cervical complex during nociception. Eur J Pain. 2024 May;28(5):719-728. doi: 10.1002/ejp.2212. Epub 2023 Nov 28.

  PMID: 38013614 BACKGROUND

• Mehnert J, Tinnermann A, Basedau H, May A. Functional representation of trigeminal nociceptive input in the human periaqueductal gray. Sci Adv. 2024 Mar 22;10(12):eadj8213. doi: 10.1126/sciadv.adj8213. Epub 2024 Mar 20.

  PMID: 38507498 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Arne May, Prof

CONTACT

+4940741059189; a.may@uke.de

Jan Mehnert, PD Dr.

CONTACT

+4940741059711; j.mehnert@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)