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

January 30, 2020 updated by: Helius Medical Inc

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3L5
        • The Montreal Neurofeedback Center
  • United States
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University Center for Regenerative Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • Willing and able to adhere to the study schedule
  • Willing to complete a neuropsychological evaluation prior to inclusion

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
  • Blood pressure abnormalities considered clinically significant
  • Use of Coumadin or other anticoagulant except aspirin in the last 6 months
  • Untreated or undiagnosed diabetes
  • Diabetic neuropathy
  • Active or recent (within 1 year) treatment for any cancer, excluding basal cell carcinoma.
  • Neurological disorders other than those attributed to the primary diagnosis (neurodegenerative diseases such as Multiple Sclerosis, Parkinson's disease, Alzheimer's disease or other dementia, Amyotrophic Lateral Sclerosis)
  • History of epileptic or other seizure disorders
  • Known ischemic heart disease and/or history or atrial or ventricular arrhythmias with or without syncope
  • Any other untreated or unstable acute or chronic, clinically significant medical condition for which the subject is currently undergoing treatment that the study investigator deems unsuitable for inclusion
  • Use of a lower extremity biomechanical prosthetic with the exception of a splint for foot drop
  • Females who are pregnant, lactating, or planning to become pregnant during the study
  • Chronic use of any potentially interfering medication, or use of any medication that would compromise the ability to function or perform the study activities
  • Addition of and/or major change in type or dosage of any prescription medication within 3 months prior to receipt of the PoNS device
  • Active alcoholism. The study investigator will have the right to exclude subject participation if the subject seems intoxicated at time of screening and/or during any study appointment.
  • History of drug abuse will be assessed
  • Recent history of smokeless tobacco use
  • Any reason that may be a threat to health or safety
  • Any finding in the neuropsychological evaluation that makes the subject unsuitable for inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PoNS Device
Cranial nerve non-invasive neuromodulation via PoNS device. The system delivers 19 V pulses to the tongue (a nominal 5.5 kilo-ohm load).
Device: Cranial nerve non-invasive neuromodulation via PoNS device
The PoNS is a medical device worn around the neck. The controller contains the pulse generator and a user interface. The mouthpiece, held to the top of the tongue, contains 143 circular gold electrodes that deliver a mild, controlled electric stimulation to the subject. While the subject is receiving stimulation, they will perform increasingly difficult balance, posture, gait, and movement control tasks designed to challenge existing abilities. Each training session takes approximately one hour to complete, and is separated by an interval of 2-2.5 hours.
Sham Comparator: Sham PoNS Device
The sham control device appears physically identical but uses a modified stimulus waveform parameter set designed to elicit a mild tactile sensation while minimizing the net energy delivered, thereby providing minimal, if any, cranial nerve non-invasive neuromodulation via PoNS device
Device: Sham PoNS device
The PoNS is a medical device worn around the neck. The controller contains the pulse generator and a user interface. The mouthpiece, held to the top of the tongue, contains 143 circular gold electrodes that deliver a mild, controlled electric stimulation to the subject. The sham control device is physically identical but uses a modified stimulus waveform parameter set designed to elicit a mild tactile sensation while minimizing the net energy delivered, minimizing any neuromodulatory effect. While the subject is receiving stimulation, they will perform increasingly difficult balance, posture, gait, and movement control tasks designed to challenge existing abilities. Each training session takes approximately one hour to complete, and is separated by an interval of 2-2.5 hours.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Response to treatment defined as an 8 point change in the Sensory Organization Test (SOT) from baseline
Time Frame: 5 weeks after the start of the intervention
The SOT is an objective, automated measure of sensory-motor integration that evaluates the functional contribution of the somatosensory, visual, and vestibular components of balance. A composite score is calculated and compared with a database normalized for age and height.
5 weeks after the start of the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Increase in SOT score from pre-training SOT score at the end of 2 weeks in lab training
Time Frame: Two weeks after start of the intervention
Two weeks after start of the intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of falls
Time Frame: Daily for 5 weeks
Daily for 5 weeks
Frequency of headaches
Time Frame: 5 weeks
Frequency of headaches will be assessed using the headache disability index
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helius Medical Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 18, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NHC-TBI-PoNS-RT001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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