An interventional study of High frequency stimulation (HFS) and Low-frequency sinusoidal transcutaneous stimulation (sLFS) in Migraine, sponsored by University Hospital Tuebingen. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-15.
Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Basic science
The proposed project aims at establishing Calcitonin gene-related peptide (CGRP)-Related Axon Reflex of Trigeminal Afferents as a neurophysiological biomarker for migraine.
The proposed project aims at establishing a neurophysiological biomarker for migraine. Migraine is one of the world's most disabling diseases and its prophylactic treatment is time and cost-consuming. Since each patient responds differently and unpredictably to preventive medication, physicians are forced to try prophylactic drugs one by one. Recently, a new group of therapeutic agents targeting the neuropeptide Calcitonin gene-related peptide (CGRP) has been launched for migraine treatment. CGRP is stored in trigeminal afferents and released to meningeal blood vessels during acute migraine attacks leading to a vasodilating response. In an experimental setting, the release of CGRP from afferent nerve fibers in the skin can be induced by transdermal electrical stimulation. The subsequently evoked skin erythema, called 'flare reaction', can be quantified by laser Doppler imaging techniques. Never before, research studies used this experimental model in either trigeminally innervated skin or migraine patients. I therefore propose to establish this model to 1) test the specificity of an evoked 'flare response' in the trigeminal territory for the pathophysiology of migraine, 2) investigate the effect of CGRP-targeting anti-migraine drugs on this outcome parameter and 3) evaluate the impact of this model to predict the treatment response to drugs interfering with the CGRP-pathway. This study is a highly innovative approach towards tailored migraine treatment.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's planned enrollment of 72 is close to the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy volunteers (Study Arm 1 and 2):
Migraine patients need to match the following criteria (Study Arm 2 and 3):
Exclusion Criteria:
Healthy volunteers and migraine patients under the following conditions will be excluded:
HFS / LFS in healthy volunteers at two different points in time
Diagnostic Test: High frequency stimulation (HFS) · Diagnostic Test: Low-frequency sinusoidal transcutaneous stimulation (sLFS)
HFS / LFS in migraine patients at a single point in time
Diagnostic Test: High frequency stimulation (HFS) · Diagnostic Test: Low-frequency sinusoidal transcutaneous stimulation (sLFS)
HFS / LFS before and under treatment with Botulinum toxin or CGRP-targeted therapy
Diagnostic Test: High frequency stimulation (HFS) · Diagnostic Test: Low-frequency sinusoidal transcutaneous stimulation (sLFS)
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.
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.
Intensity of axonal flare reaction
Axon reflex erythema of stimulated C-nociceptors measured in Flux (luminous flux) values 0 - 100.
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University Hospital Tuebingen