Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED NA

PoNS Clinical Experience Program in Traumatic Brain Injury Patients (TBI)

NCT03881176 · View on ClinicalTrials.gov ↗

Study Summary

\- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device. Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.

Interventions

  • DEVICE PoNS Treatment

Study Locations (1)

New York

  • North Shore University Hospital — Manhasset

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2018-09-21
Est. Completion 2019-11-30
Phase NA

Sponsor

Helius Medical

3 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03881176

The ClinicalTrials.gov registry entry for NCT03881176 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Helius Medical, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Mild to Moderate Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention — of which PoNS Treatment is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03881176 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03881176 about?

NCT03881176 is a clinical study titled "PoNS Clinical Experience Program in Traumatic Brain Injury Patients (TBI)". \- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical ex...

What is the current status of trial NCT03881176?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2018-09-21. Estimated completion is 2019-11-30.

What conditions does trial NCT03881176 study?

This clinical trial studies the following conditions: Mild to Moderate Traumatic Brain Injury. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03881176?

The interventions under investigation include: PoNS Treatment (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03881176?

This trial is sponsored by Helius Medical, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03881176 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial