Loading clinical trials...

COMPLETEDNA

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

Double Blind, Randomized, Sham Controlled Study of Safety and Effectiveness of the Portable Neuromodulation Stimulator (PoNS) Device for Cranial Nerve Noninvasive Neuromodulation Training for Chronic Balance Deficit Due to Mild/Moderate TBI

NCT02429167•Helius Medical Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, 18-65 years of age
•Documentation on initial TBI (defined as closed-head, non-penetrating, blunt, whiplash, or explosive blast-induced brain injury) severity (at time of injury): Glasgow Coma Scale (GCS) score 9-15, with loss of consciousness \< 24 hours, post-traumatic amnesia ≤7 days, or hospital admission ≤ 7 days post TBI
•If female, subject is not pregnant, not lactating, has a negative pregnancy test prior to receipt of the PoNS™ device, and agrees to use contraception from screening to end of the study
•Balance disorder with SOT composite score at least 16 points below normal resulting from a mild/moderate TBI without any concomitant pathologies
•At least 1 year post injury
•Stable neurologic status
•Prior participation in a focused physical rehabilitation program for TBI and deemed by their treating clinician/themselves to have reached a plateau
•Able to walk continuously on a treadmill for 20 minutes, level grade and at any speed, with support if needed
•Access to a treadmill and commitment to utilize this for the at-home portion of the study
•Able to understand the study procedures and give informed consent
+2 more criteria

Exclusion Criteria

•Medical finding from screening history and physical examination that is clinically significant or would otherwise impact patient safety or data integrity
•Medical finding from prior neuroradiologic study or recent MRI that is significant or that would impact patient safety or data integrity
•Planned use or use of any investigational product, pharmaceutical or device within 30 days preceding receipt of the PoNS device and during the entire study
•Balance or gait deficits due to lower extremity injury or neurological condition other than TBI
•Penetrating brain injury, craniotomy or refractory subdural hematoma
•Oral health problems at the time of recruitment
•Oral surgery within 3 months of screening
•History of oral cancer
•Non-removable metal orthodontic devices that could interfere with PoNS use
•Presence of metallic implant or other MRI-incompatible device
+18 more criteria

Locations (3)

Orlando Health

Orlando, Florida, United States

Oregon Health and Science University Center for Regenerative Medicine

Portland, Oregon, United States

The Montreal Neurofeedback Center

Montreal, Quebec, Canada

Key Dates

Start Date

August 1, 2015

Primary Completion Date

August 18, 2017

Completion Date

August 18, 2017

Last Updated

February 7, 2020

Enrollment

122

ACTUAL participants

Conditions

Traumatic Brain InjuryChronic Balance Disorder

Interventions

Cranial nerve non-invasive neuromodulation via PoNS device

DEVICE

Sham PoNS device

DEVICE

Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

NCT04521881

Traumatic Brain Injury

View study

RECRUITING

A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury

NCT07455136

Traumatic Brain Injury

View study

RECRUITING

Hemodynamic ABI Monitor

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury

Hemodynamic ABI Monitor

Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury

Carbon Dioxide Administration and Brain Waste Clearance

Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury