Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis

The Registry will be designed to gather information over 3 years. This important health economic information will help to establish the value of the PoNS Device on key therapeutic outcomes. These outcomes will include: disease-associated injury risks (i.e., falls), onset of new comorbidities and/or worsening/improvement of existing medical condition(s) (other than gait deficit/impairment), need for new pharmacological/non-pharmacological intervention or increase/decrease of ongoing pharmacotherapy or other non-pharmacological intervention, increase/decrease of in patient/outpatient hospital and/or office visits or stays, side effects. By participation in the Registry, patients and physicians will be providing Helius with access to information about medical history, medical diagnoses, clinical symptom presentations, vocational information, medications, pharmacologic and non-pharmacologic prescriptions, hospitalization and healthcare visits, and any reported therapy's adverse events.

NCT Number	NCT06930339
Lead Sponsor	Helius Medical Inc
Conditions	Multiple Sclerosis
Enrollment	150 participants
Start Date	2023-05-01
Primary Completion	2026-04-30 (estimated)
Study Completion	2026-04-30 (estimated)
Updated on ClinicalTrials.gov	2025-04-16