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

NCT ID: NCT06535880

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2027-12-31

Brief Summary

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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

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

Conditions

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Migraine Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Electric Stimulation

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

Group Type EXPERIMENTAL

Electric Current Stimulation

Intervention Type DEVICE

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

Interventions

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Electric Current Stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* healthy
* suitable fo MRI

Exclusion Criteria

* headache disease
* psychological disorder
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Arne May, Prof

Role: CONTACT

+4940741059189

Jan Mehnert, PD Dr.

Role: CONTACT

+4940741059711

Facility Contacts

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Arne May, Prof

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 37203351 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38013614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38507498 (View on PubMed)

Other Identifiers

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TrigeminalBrainstemMapping2

Identifier Type: -

Identifier Source: org_study_id

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