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:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT03047460
Eligibility Criteria:
Inclusion Criteria:
* To be eligible to participate in this study, candidates must meet the following eligibility criteria at Screening, or at the time point specified in the individual eligibility criterion listed (HV cohort):
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
2. Aged 18 to 58 years old, inclusive, at the time of informed consent.
3. Have no significant health issues, ie neuropathy or other demyelinating disorder that can affect testing.
Inclusion Criteria (MS Cohort)
To be eligible to be included in this cohort, candidates must meet the following additional eligibility criteria at Screening:
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
2. Aged 18 to 58 years old, inclusive, at the time of informed consent.
3. Diagnosis of MS (all types) with an expanded disability status scale (EDSS) 0.0 to 6.5.
4. Have measurable responses on both MEP and SSEP in at least one upper and one lower limb. The MEP and SSEP responses do not need to be in the same limb
5. Have no comorbid condition (ie neuropathy) that could affect testing.
Exclusion Criteria:
* Candidates will be excluded from study entry if any of the following exclusion criteria exist at screening or at any time during the study.
1. Inability to comply with study requirements.
2. Unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.
3. Any diseases (e.g., non-MS demyelinating diseases), with the exception of diagnosis MS for the MS Cohort, that in the opinion of the Investigator, could influence evoked potential results ( including but not limited to medullary trauma, morbid obesity, limb amputation, diabetes, other polyneuropathy).
4. MS relapse within 3 months of either sessions.
5. Initiation of treatment or dose adjustment within 1 month of either sessions with Fampyra, Tegretol, Baclofen, Zanaflex
6. Febrile illness within 3 days of either sessions.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
58 Years
Study:
NCT03047460
Study Brief:
Protocol Section:
NCT03047460