Human Electrophysiological Model to Quantify the CGRP-related Axon Reflex of Trigeminal Afferents (NCT04796766) | Clinical Trial Compass
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Human Electrophysiological Model to Quantify the CGRP-related Axon Reflex of Trigeminal Afferents
Germany72 participantsStarted 2021-02-01
Plain-language summary
The proposed project aims at establishing Calcitonin gene-related peptide (CGRP)-Related Axon Reflex of Trigeminal Afferents as a neurophysiological biomarker for migraine.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 forehea…