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

April 8, 2025 updated by: Helius Medical Inc

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Newtown, Pennsylvania, United States, 18940
        • Helius Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria: none

  • Diagnosis of gait deficit due to MS

Exclusion Criteria: none

  • unable to ambulate with or without an assisting device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helius Medical Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMI-MS-PoNS-RE001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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