Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis

Condition(s) studied

Investigational drug(s) / intervention(s)

Portable Neuromodulation Stimulator (PoNS): No intervention

Study summary

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.

Eligibility

Primary outcome measure(s)

• Effectiveness of PoNS Therapy as measured by self-reported change in symptomatology — 3 years
  Balance and Gait deficit improvement after physical therapy rehabilitation with PoNS device over one or more courses of 14-week therapy

Trial sites (1)

More Helius Medical Inc trials in the USA

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