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Human Electrophysiological Model to Quantify the CGRP-related Axon Reflex of Trigeminal Afferents

NCT04796766 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-12-15

No results posted yet for this study

Summary

The proposed project aims at establishing Calcitonin gene-related peptide (CGRP)-Related Axon Reflex of Trigeminal Afferents as a neurophysiological biomarker for migraine.

Conditions

Interventions

DIAGNOSTIC_TEST

High frequency stimulation (HFS)

Electrical stimuli via circular electrode array. The electrode array serves as cathode placed above the eyebrow. A surface electrode (anode) will be placed on the temple. Electrical stimuli will be applied via a constant current stimulator. The stimulus intensity for the electrophysiological protocol is adjusted to the 10-fold of the detection threshold. A number of 5 electrical pulses (2 ms, 100 Hertz (Hz)), 10 second intervals.

DIAGNOSTIC_TEST

Low-frequency sinusoidal transcutaneous stimulation (sLFS)

Stimulation of C-nociceptors with constant current stimulator. Electrodes (placed on the proband's forehead. Stimulation by sine wave pulses of 250 ms duration (4 Hz), intensities inducing a pain intensity of 50/100 on a visual analogue scale from 0-100.

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Sigrid Schuh-Hofer, Prof. Dr. · University Hospital Tübingen

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04796766 on ClinicalTrials.gov