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Neuromodulation Device

Single Arm for Stroke Survivors

Phase 2 & 3
Recruiting
Research Sponsored by Helius Medical Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 week
Awards & highlights

Study Summary

This trial aims to assess the safety and effectiveness of PoNS therapy in chronic stroke survivors. The study will also look at how PoNS therapy affects dynamic gait and balance, durability of effects, risk

Who is the study for?
This trial is for chronic stroke survivors who are experiencing issues with walking and balance. Participants should be able to commit to the study duration and follow-up requirements. Specific eligibility details aren't provided, but typically, trials exclude individuals with conditions that could interfere with the treatment or skew results.Check my eligibility
What is being tested?
The trial is testing PoNS Therapy—a device aimed at improving gait and balance in people who have had a stroke. The study will look at safety, how well it works for walking and balance, its lasting effects, fall risks, adherence to using the device, and overall quality of life.See study design
What are the potential side effects?
While specific side effects are not detailed here, safety is a primary focus of this trial. Generally speaking, neuromodulation devices like PoNS may cause discomfort or skin irritation where applied; other potential side effects would be monitored throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary safety endpoints

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
open label administration of translingual neurostimulation.

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Who is running the clinical trial?

Helius Medical IncLead Sponsor
8 Previous Clinical Trials
286 Total Patients Enrolled
Antonella Favit-VanPeltLead Sponsor
~20 spots leftby Apr 2025
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