Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis

NCT ID: NCT06930339

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2026-04-30

Brief Summary

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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

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Portable Neuromodulation Stimulator (PoNS)

No intervention

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of gait deficit due to MS

Exclusion Criteria

* unable to ambulate with or without an assisting device
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helius Medical Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Helius Medical

Newtown, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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HMI-MS-PoNS-RE001

Identifier Type: -

Identifier Source: org_study_id

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