Status:
UNKNOWN
Human Electrophysiological Model to Quantify the CGRP-related Axon Reflex of Trigeminal Afferents
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04796766
Start Date
February 1 2021
End Date
December 1 2024
Last Update
December 15 2023
Active Locations (1)
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1
University Hospital Tübingen
Tübingen, Germany, 72076