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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 week

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Helius Medical IncLead Sponsor

8 Previous Clinical Trials

286 Total Patients Enrolled

Antonella Favit-VanPeltLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the criteria for eligibility to participate in this research?

"Candidates eligible for participation in this trial must be individuals who have survived a stroke and are between the ages of 18 and 85. The study aims to enroll approximately 30 participants."

Answered by AI

Are there still opportunities for patients to participate in this ongoing research study?

"As per clinicaltrials.gov, this ongoing research study is actively seeking eligible candidates. The trial's initial posting was on April 1st, 2024, with the most recent update made on March 26th of the same year."

Answered by AI

What is the total number of participants involved in this clinical research study?

"Indeed, records on clinicaltrials.gov suggest that this study is actively enrolling volunteers. The trial was initially posted on April 1st, 2024 and last modified on March 26th, 2024. Enrollment for the trial is open to a total of 30 participants at one site."

Answered by AI

Does this study allow participation for individuals older than 25 years of age?

"Potential participants for this study must be between 18 and 85 years old. There are a total of 41 trials catering to individuals under 18, while there is a pool of 1121 trials dedicated to those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PoNS® Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study

Antonella Favit-VanPelt 2024. "PoNS® Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06336720.

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