Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis

Active, not recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT06930339
• Lead Sponsor: Helius Medical Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

none

• Diagnosis of gait deficit due to MS

Exclusion Criteria

none

• unable to ambulate with or without an assisting device

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Helius Medical; 🇺🇸 Newtown, Pennsylvania, United States