Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis (PoNSREM)

Helius Medical

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Device: Portable Neuromodulation Stimulator (PoNS)

Study type: Observational

Funder types: Industry

Identifiers

NCT06930339

HMI-MS-PoNS-RE001

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: none

• Diagnosis of gait deficit due to MS

Exclusion Criteria: none

• unable to ambulate with or without an assisting device