Traumatic Brain InjuryNCT02429167
Study of Safety and Effectiveness of PoNS Device to Treat Chronic Balance Deficit Due to Traumatic Brain Injury (TBI)
A study testing Cranial nerve non-invasive neuromodulation via PoNS device in people with Traumatic Brain Injury and Chronic Balance Disorder, run by Helius Medical Inc at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury, Chronic Balance Disorder
- What is being tested?
- Cranial nerve non-invasive neuromodulation via PoNS device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2015to 18 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Orlando Health
Orlando, Florida, 32806
Oregon Health and Science University Center for Regenerative Medicine
Portland, Oregon, 97239
About this study
Official title: 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.
- Conditions
- Traumatic Brain Injury, Chronic Balance Disorder
- Being tested
- Cranial nerve non-invasive neuromodulation via PoNS device, Sham PoNS device
- Keywords
- Traumatic Brain Injury, Neuromodulation, Chronic Balance Disorder
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial nerve non-invasive neuromodulation via PoNS deviceDevice
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 PoNS deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PoNS Device | Experimental | Cranial nerve non-invasive neuromodulation via PoNS device. The system delivers 19 V pulses to the tongue (a nominal 5.5 kilo-ohm load). Receives: Device: Cranial nerve non-invasive neuromodulation via PoNS device |
| Sham PoNS Device | Sham comparator | 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 Receives: Device: Sham PoNS device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment defined as an 8 point change in the Sensory Organization Test (SOT) from baseline
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.
Measured: 5 weeks after the start of the intervention
Secondary outcomes (1)
Increase in SOT score from pre-training SOT score at the end of 2 weeks in lab training
Measured: Two weeks after start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startAug 2015
- Primary completion18 Aug 2017
- Study completion18 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helius Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429167
- Sponsor's protocol ID
- NHC-TBI-PoNS-RT001
- Status last verified
- Jan 2020
- First submitted
- 20 Apr 2015
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02429167
- Acronym / sponsor ID
- NHC-TBI-PoNS-RT001
- Conditions
- Traumatic Brain Injury, Chronic Balance Disorder
- Keywords
- Traumatic Brain Injury, Neuromodulation, Chronic Balance Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Helius Medical IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- 18 Aug 2017 (actual)
- Study completion
- 18 Aug 2017 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PoNS Device | Experimental | Device: Cranial nerve non-invasive neuromodulation via PoNS deviceCranial nerve non-invasive neuromodulation via PoNS device. The system delivers 19 V pulses to the tongue (a nominal 5.5 kilo-ohm load). |
| Sham PoNS Device | Sham comparator | Device: Sham PoNS deviceThe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranial nerve non-invasive neuromodulation via PoNS deviceThe 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. | Device | PoNS Device |
| Sham PoNS deviceThe 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. | Device | Sham PoNS Device |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial nerve non-invasive neuromodulation via PoNS device in people with Traumatic Brain Injury and Chronic Balance Disorder, run by Helius Medical Inc at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.