Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT04796766
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04796766
Study Brief:
Protocol Section:
NCT04796766