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Active, not recruitingNCT06930339PoNSREMUpdated Apr 16, 2025

Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis

An observational study in Multiple Sclerosis, sponsored by Helius Medical Inc. Active, not recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-04-16.

Sponsored by Helius Medical Inc · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
22 Years and older
Sex
All
01

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.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • Gait deficit, PoNS
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Helius Medical Inc is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
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.

Eligibility criteria

Inclusion Criteria: none

  • Diagnosis of gait deficit due to MS

Exclusion Criteria: none

  • unable to ambulate with or without an assisting device
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Interventions

  • DevicePortable Neuromodulation Stimulator (PoNS)

    No intervention

06

What researchers measure

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

    Time frame: 3 years

07

Study locations

1 site
  • Helius Medical
    Newtown, Pennsylvania 18940, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06930339
Lead sponsor
Helius Medical Inc
Responsible party
Sponsor
First posted
Apr 16, 2025
Start date
May 1, 2023
Primary completion
Apr 30, 2026 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Apr 16, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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