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OpenTrials
Active, Not Recruiting

NCT Number: NCT06930339

Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helius Medical

Newtown, Pennsylvania, 18940, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

none

  • Diagnosis of gait deficit due to MS

Exclusion criteria

none

  • unable to ambulate with or without an assisting device

Treatment and study plan

Portable Neuromodulation Stimulator (PoNS)

Device

No intervention

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Helius Medical Inc

Industry

Registry information

Acronym: PoNSREM

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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