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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 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. The trial reports 1 study location across 1 state.
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.
Conditions Studied
Interventions
- DEVICE PoNS Treatment
Study Locations (1)
New York
- North Shore University Hospital - Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-09-21 |
| Est. Completion | 2019-11-30 |
| Phase | NA |
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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, categorized as NA. 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 5 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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