Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis

NCT06930339 | Active Not Recruiting FDA Device

• 1 other identifier: HMI-MS-PoNS-RE001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Gait deficit, PoNS

Outcome Measures

Primary Outcomes (1)

• Effectiveness of PoNS Therapy as measured by self-reported change in symptomatology

  Balance and Gait deficit improvement after physical therapy rehabilitation with PoNS device over one or more courses of 14-week therapy

  3 years

Interventions

Portable Neuromodulation Stimulator (PoNS) DEVICE

No intervention

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The registry is designed to collect retrospective clinical/medical outcome data on the therapeutic response of MS patients with gait deficit who underwent at least an initial 14-week PoNS Therapy course.

You may qualify if:

• Diagnosis of gait deficit due to MS

You may not qualify if:

• unable to ambulate with or without an assisting device

Sponsors & Collaborators

• Helius Medical Inc: lead

Study Sites (1)

Helius Medical

Newtown, Pennsylvania, 18940, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 16, 2025
• Study Start: May 1, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-03

Locations

US (1)