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

NCT ID: NCT04796766

Last Updated: 2023-12-15

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Migraine

Keywords

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Migraine Calcitonin gene-related peptide (CGRP) Evoked flare response

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

HFS / LFS in healthy volunteers at two different points in time

Group Type EXPERIMENTAL

High frequency stimulation (HFS)

Intervention Type DIAGNOSTIC_TEST

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.

Low-frequency sinusoidal transcutaneous stimulation (sLFS)

Intervention Type DIAGNOSTIC_TEST

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.

Migraine patients

HFS / LFS in migraine patients at a single point in time

Group Type EXPERIMENTAL

High frequency stimulation (HFS)

Intervention Type DIAGNOSTIC_TEST

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.

Low-frequency sinusoidal transcutaneous stimulation (sLFS)

Intervention Type DIAGNOSTIC_TEST

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.

Patients with Botulinum toxin or CGRP-targeted therapy

HFS / LFS before and under treatment with Botulinum toxin or CGRP-targeted therapy

Group Type EXPERIMENTAL

High frequency stimulation (HFS)

Intervention Type DIAGNOSTIC_TEST

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.

Low-frequency sinusoidal transcutaneous stimulation (sLFS)

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Healthy volunteers (Study Arm 1 and 2):

* age ≥ 18 years
* good German language skills
* no history of head trauma
* no history of neurologic disease
* no primary headache disorder (e.g. migraine, episodic or chronic tension type headache, cluster headache)
* no regular drug intake (except for oral contraceptives)

Migraine patients need to match the following criteria (Study Arm 2 and 3):

* age ≥ 18 years
* good German language skills
* fulfilling the diagnostic criteria for either episodic or chronic migraine with or without aura according to the international classification of headache disorders (ICHD) 3rd edition
* history of migraine \> 1 year
* keeping a headache diary for a minimum of 3 months prior to the study

Exclusion Criteria

Healthy volunteers and migraine patients under the following conditions will be excluded:

* Chronic pain syndromes (e.g. low back pain, osteoarthritis, painful neuropathy, rheumatoid arthritis)
* Acute pain (e.g. pain due to acute skin injury, menstrual pain, acute toothache). In this case, a measurement can only be performed after complete remission of pain and at least 48 hours after intake of acute pain medication (e.g. triptans, non-steroidal anti-inflammatory drug (NSAID)).
* history of treatment with agents targeting the CGRP pathway (e.g. erenumab) \< 3 months before the study
* history of treatment with Botulinum toxin \< 9 months before the study
* Diseases of the skin involving the skin at face and forehead
* Pregnancy or breast feeding
* Subjects lacking capacity for consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sigrid Schuh-Hofer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tübingen

Locations

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University Hospital Tübingen

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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MiPro-CGRP

Identifier Type: -

Identifier Source: org_study_id