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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT06413602
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of relapsing form of MS
* Expanded Disability Status Scale (EDSS) score of at least 3 and no more than 6.5
* Motor Functional Systems Score (FSS) between 2-4
* Relapse free for at least 1 year
* Age ≥18 years and ≤75 years
* Safe to participate in MRI (as indicated via the SRALab MRI questionnaire)
* No change in Dalfampridine dose at least 2 months prior to enrollment
Exclusion Criteria:
* Uncontrolled hypertension or hypotension (outside 140/90 and 90/60 mmHg)
* History of epilepsy or seizures
* Uncontrolled medical problems affecting the lungs (pulmonary diseases including chronic obstructive pulmonary disease), the heart (cardiovascular diseases) or the musculoskeletal system (orthopedic diseases)
* Premorbid, ongoing major depression or psychosis, altered cognitive status
* History of stroke
* Metal in head (e.g., surgical clips, shrapnel)
* Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
* Surgery to the head
* Any non-MS related neurological diseases
* Illnesses that may have caused brain injury
* Unexplained frequent or severe headaches
* Pregnancy in females
* Implanted devices (e.g., pacemakers, medical pumps, brain stimulators)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06413602
Study Brief:
Protocol Section:
NCT06413602