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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT03874351
Eligibility Criteria:
Inclusion Criteria:
* Age 18 - 65 years;
* Has episodic or chronic migraine with or without aura, diagnosed according to the International Classification of Headache Disorders 3rd edition (ICHD-3) criteria, for at least the past 12 months;
* Migraine occurring on 4 or more days per month, as documented through the 30-day baseline;
* No change in prophylactic therapy in 3 months preceding the baseline;
* If on antidepressant, blood pressure or epilepsy medication for reason other than migraine, the medication regimen is stable for at least 3 months preceding the baseline; Able to follow instructions in English;
* Understand the informed consent process and provide consent to participate in the study.
Exclusion Criteria:
* History of severe head trauma, brain surgery, implants in the head or neck; history of seizures;
* Skin disorder or skin defects which compromise the integrity or sensitivity of the skin at or near locations where tDCS will be applied;
* Not able to prepare and operate the tDCS device after being instructed in tDCS use;
* Not able to respond to questionnaires and rating scales;
* Concurrent use of another neurostimulation device (such as spinal cord stimulator cardiostimulator, deep brain stimulator, vagus nerve, transcranial magnetic, or supraorbital transcutaneous electric nerve stimulators);
* Concurrent use of Botox or calcitonin gene-related peptide (CGRP) monoclonal antibodies treatments;
* Unstable acute medical condition;
* Any serious, malignant or non-malignant, acute or chronic medical condition or active psychiatric illness that, in the Investigator's opinion, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study;
* Used any investigational drug, biologic, or device within 30 days prior to screening, or 5 half-lives, whichever is longer;
* Taking opioid analgesics or barbiturates on more than 2 days a week;
* Taking medications acting as antagonist on the N-methyl-D-aspartate (NMDA) receptor.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03874351
Study Brief:
Protocol Section:
NCT03874351