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 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT04495556
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for participants with typical presentations will include:
1. Age 18 to 65 inclusive
2. Referral to a study academic site for a clinical suspicion of MS
3. Onset with typical symptom onset including: acute unilateral optic neuritis, double vision due to an internuclear ophthalmoplegia or sixth nerve palsy, facial sensory loss or trigeminal neuralgia in a young adult (\<40 years of age), cerebellar ataxia and nystagmus, partial myelopathy, sensory symptoms in a CNS pattern, Lhermitte's symptom, asymmetric limb weakness, urge incontinence or erectile dysfunction, or other neurological presentation considered to be typical by the site investigator.
4. Able to provide written informed consent to participate in the study
5. For participants referred for clinical suspicion of multiple sclerosis who had workup prior to referral or who are taking disease-modifying therapies for MS, digital availability of diagnostic cranial MRI with gadolinium within 3 months of initial symptoms
6. Onset of typical neurological symptoms within 10 years of screening.
Inclusion criteria for participants with atypical presentations will include:
1. Age 18 to 65 inclusive
2. Referral to a study academic site for a suspicion of MS
3. Onset with atypical onset including: bilateral optic neuritis or unilateral optic neuritis with a poor visual recovery, complete gaze palsy or fluctuating ophthalmoparesis, intractable nausea, vomiting, or hiccups, complete transverse myelopathy with bilateral motor and sensory involvement, encephalopathy, subacute cognitive decline, headache or meningismus, isolated fatigue or asthenia, constitutional symptoms, other clinical presentations considered atypical by the site investigator (examples include: vague or patchy sensory symptoms, pain, short lasting bilateral blurred vision, etc.), or absence of clinical symptoms with MRI features suggestive of MS
4. Able to provide written informed consent to participate in the study
5. For participants referred for clinical suspicion of multiple sclerosis who had workup prior to referral or who are taking disease-modifying therapies for MS, digital availability of diagnostic cranial MRI with gadolinium within 3 months of initial symptoms
6. Onset of atypical neurological symptoms within 10 years of screening.
Exclusion Criteria:
Exclusion criteria for both typical and atypical populations will include:
1. Contraindication to MRI studies; metal or metal implants incompatible with MRI
2. Inability to tolerate MRI due to claustrophobia or known excessive movement (e.g. tremor)
3. Contraindication to use of gadolinium containing contrast agents (allergy or renal failure)
4. Treatment with systemic corticosteroids in the 4 weeks preceding enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04495556
Study Brief:
Protocol Section:
NCT04495556