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NCT03881176 · ClinicalTrials.gov registry record · NA

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

A NA study of Mild to Moderate Traumatic Brain Injury, sponsored by Helius Medical.

Completed
Registry status
NA
Development phase
20
Enrollment target
1
Study location

NCT03881176: Completed NA study of Mild to Moderate Traumatic Brain Injury, sponsored by Helius Medical.

NCT03881176 is a NA study of Mild to Moderate Traumatic Brain Injury that has completed, run by Helius Medical. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03881176, a NA study of Mild to Moderate Traumatic Brain Injury, has completed, sponsored by Helius Medical.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target
1
Study location

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
Helius Medical

5 total trials

What the finished NCT03881176 record still lists

NCT03881176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

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.

NCT03881176 reports a single indexed study location in New York.

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.

What interventions are being tested in trial NCT03881176?

The interventions under investigation include: PoNS Treatment (DEVICE).

Who is sponsoring clinical trial NCT03881176?

This trial is sponsored by Helius Medical, which has 5 total clinical trials registered on ClinicalTrials.gov.

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.

How this trial's enrollment target compares

Where NCT03881176's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03881176, the US trial registry maintained by the National Library of Medicine. NCT03881176 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.