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Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis

Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06930339
Acronym
PoNSREM
Enrollment
150
Registered
2025-04-16
Start date
2023-05-01
Completion date
2026-04-30
Last updated
2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Gait deficit, PoNS

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.

Interventions

Sponsors

Helius Medical Inc
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No

Inclusion criteria

none * Diagnosis of gait deficit due to MS

Exclusion criteria

none * unable to ambulate with or without an assisting device

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of PoNS Therapy as measured by self-reported change in symptomatology3 yearsBalance and Gait deficit improvement after physical therapy rehabilitation with PoNS device over one or more courses of 14-week therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026