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NCT02429167 · ClinicalTrials.gov registry record · NA

Study of Safety and Effectiveness of PoNS Device to Treat Chronic Balance Deficit Due to Traumatic Brain Injury (TBI)

A NA study, sponsored by Helius Medical.

Completed
Registry status
NA
Development phase
122
Enrollment target

NCT02429167 is a NA study that has completed, run by Helius Medical. The registered enrollment target is 122 participants.

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The verdict

NCT02429167, a NA study, has completed, sponsored by Helius Medical.

COMPLETED
Registry status
NA
Development phase
122 participants
Enrollment target

Study Summary

The purpose of this study is to determine if clinic and home training with a study device will improve a balance deficit. The study device is called Portable Neuromodulation Stimulator (PoNS). The study device will be placed on the tongue to deliver nerve stimulation. The study is testing if use of the study device in conjunction with physical therapy will improve balance and gait in patients suffering from a TBI. The effects of using the device and undergoing therapy will be measured using standardized tests of movement control, gait, headache and other TBI symptoms.

Interventions

  • DEVICE Cranial nerve non-invasive neuromodulation via PoNS device
  • DEVICE Sham PoNS device

Trial Details

FieldValue
Enrollment Target 122 participants
Start Date 2015-08
Est. Completion 2017-08-18
Phase NA

Sponsor

Helius Medical

5 total trials

What the Registry Record Tells You About NCT02429167

The ClinicalTrials.gov registry entry for NCT02429167 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 122 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 0 conditions, and to 2 interventions - of which Cranial nerve non-invasive neuromodulation via PoNS device is the first listed.

NCT02429167 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02429167 about?

NCT02429167 is a clinical study titled "Study of Safety and Effectiveness of PoNS Device to Treat Chronic Balance Deficit Due to Traumatic Brain Injury (TBI)". The purpose of this study is to determine if clinic and home training with a study device will improve a balance deficit. The study device is called Portable Neuromodulation Stimulator (PoNS). The study device will be placed on the tongue to deliver nerve stimulation. The study is testing if use of ...

What is the current status of trial NCT02429167?

This trial is currently completed. It is a NA study. The enrollment target is 122 participants. The study started on 2015-08. Estimated completion is 2017-08-18.

What interventions are being tested in trial NCT02429167?

The interventions under investigation include: Cranial nerve non-invasive neuromodulation via PoNS device (DEVICE), Sham PoNS device (DEVICE).

Who is sponsoring clinical trial NCT02429167?

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

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

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