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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT06816004
Eligibility Criteria:
Inclusion Criteria:
* Female
* Age 25-65 years (inclusive)
* Definite diagnosis of MS or related demyelinating disorders (e.g., Neuromyelitis Optica or NMO)
* Stable high efficacy DMT ≥ 6 months before enrollment and throughout the trial
* PDDS score ≤ 6 (established to be able to complete procedures)
* SymptoMScreen Score ≥12
* WRAT-5 ≥85
* SDMT z-score \> -3.0
* K10 \< 35
* Stable disease activity, defined as being more than 1 month after a clinical relapse or confirmed radiologic disease activity, or more than 1 month after steroid treatment
* Ability to use mobile devices
Exclusion Criteria:
* Primary neurologic disorder other than MS and related demyelinating disorders like NMO (e.g., stroke, Parkinson's disease, spinal cord injury, intracranial mass, traumatic brain injury (TBI), epilepsy, mild cognitive impairment (MCI), or dementia), psychiatric disorders or major medical disorders (e.g., history of myocardial infarction, diabetes, thyroid disease, arrhythmia, atrial fibrillation)
* Diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS)
* History of vagus nerve surgery/vagotomy
* History of diagnosed cardiovascular disease, a heart transplant, presence of permanent pacemaker implant or Left Ventricular Assist Device
* Use of certain medications that can affect heart rate variability, such as beta-blockers, calcium channel blockers, and cardiac glycosides
* Use of SP1 inhibitor medications such as Fingolimod, Siponimod, Ozanimod, and Ponesimod
* Nicotine use in the past 6 months (smoking/vaping)
* Pregnant or planning pregnancy during the study period or breastfeeding
* Seizure disorder or recent (\<5 years) seizure history
* Active ear infections or ear pathology
* Current presence of implanted vagus nerve stimulator or any other active implanted electronic devices (e.g., pacemaker, defibrillators, cochlear implants, DBS, iVNS, etc.)
* Presence of metal objects in the head/neck
* Any skin disorder or skin sensitive area near stimulation locations
* BMI ≥ 35
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT06816004
Study Brief:
Protocol Section:
NCT06816004