Trigeminal Brainstem Mapping

NCT03999060 | Completed

• 1 other identifier: TrigeminalBrainstemMapping
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To what extent the somatotopy of the 3 branches of the trigeminal nerve (V1,V2,V3) as well as the greater occipital nerve (GON) in the brainstem but also in the thalamus and the insula can be mapped using functional imaging and BOLD in humans is not known but might play an important role in imaging headache diseases. The aim is to map their somatotopy by random stimulation of V1, V2, V3 and the GON with painful electrical input during acquisition of BOLD-fMRI.

Conditions

Headache Disorders, Primary; Migraine

Outcome Measures

Primary Outcomes (3)

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

  At a statistical threshold of T-value 3 we will observe a somatotopical arrangement in the brainstem below the pons: Expected location for V1: within radius of 10 mm around the MNI coordinates (-1,-48,-75); Expected location for V2: within radius of 10 mm around the MNI coordinates (-4,-47,-69) Expected location for V3: within radius of 10 mm around the MNI coordinates (-1,-46,-66) Expected location for GON: within radius of 10 mm around the MNI coordinates (-1,-45,-64)

  through study completion, an average of 9 months

• Statistical Parametric Map calculated from the fMRI data in the thalamus

  At a statistical threshold of T-value 4 we will observe a somatotopical arrangement in the thalamus: Expected location for V1: within radius of 10 mm around the MNI coordinates (11,-5,6); Expected location for V2: within radius of 10 mm around the MNI coordinates (13,-11,5) Expected location for V3: within radius of 10 mm around the MNI coordinates (12,-10,5) Expected location for GON: within radius of 10 mm around the MNI coordinates (15,-12,-7)

  through study completion, an average of 9 months

• Statistical Parametric Map calculated from the fMRI data in the insula

  At a statistical threshold of T-value 4 we will observe a somatotopical arrangement in the insula: Expected location for V1: within radius of 10 mm around the MNI coordinates (38,-15,8); Expected location for V2: within radius of 10 mm around the MNI coordinates (37,-8,-5) Expected location for V3: within radius of 10 mm around the MNI coordinates (39,2,-11) Expected location for GON: within radius of 10 mm around the MNI coordinates (38,-12,-3)

  through study completion, an average of 9 months

Secondary Outcomes (2)

• Statistical Parametric Map calculated from the fMRI data in the cerebellum

  through study completion, an average of 9 months

• Statistical Parametric Map calculated from the fMRI data in the periaqueductal gray (PAG)

  through study completion, an average of 9 months

Study Arms (1)

Electric Stimulation

EXPERIMENTAL

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

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)

UKE

Hamburg, 20246, Germany

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Headache Disorders, Primary; Migraine Disorders

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Arne May, Prof. Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

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: June 13, 2019
• First Posted: June 26, 2019
• Study Start: June 28, 2019
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)