Brain Injuries, TraumaticNCT02158494
Noninvasive Neuromodulation for Treatment of Symptoms Due to Mild or Moderate Traumatic Brain Injury
A study testing Balance and Gait Training using neurostimulation modulation. in people with Brain Injuries, Traumatic, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The investigators hypothesis is that electrical stimulation to the tongue that directly stimulates two cranial nerve nuclei (Trigeminal and Facial Nerve Nuclei), will excite neural impulses to the brainstem and cerebellum. The investigators call this cranial nerve non-invasive neuromodulation (CN-NINM). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Balance and Gait Training using neurostimulation modulation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All candidates will have a balance disorder as a result of a traumatic brain injury (TBI).
- All candidates will have a NeuroCom® Sensory Organization Test (SOT) composite score at least 8 points below normal after adjustment for age and height [based on normative data].
- All candidates will be between the ages of 18 and 65 (at the time of screening).
- If female of childbearing potential, the candidate agrees to use adequate contraception throughout participation in the study (from enrollment to completion).
- All candidates must have access to a treadmill.
- All candidates will be at least 1 year post-injury.
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- All candidates will have a neuroradiologic scan and report after their most recent TBI.
- All candidates will be ambulatory and able to walk for 20 minutes.
- All candidates, if on medications, will not have had any major changes in type or dosage within 3 months of enrollment.
- All candidates will have participated in a focused physical rehabilitation program for their TBI and feel that they have reached a plateau.
- All candidates will be able to understand and willing to give informed consent.
Who cannot join
- All candidates that have oral health problems (e.g. gum disease, active cankers, piercings, oral surgery within the previous 3 months).
- All candidates with non-removable metal orthodontic devices (e.g., braces) or oral cavity piercings that could interfere with PoNS™ use.
- All candidates who have chronic infectious diseases (e.g. hepatitis, HIV, TB).
- All candidates with unmanaged hypertension.
- All candidates with unmanaged diabetes, or complications due to diabetes (e.g. retinopathy, neuropathy, renal disease).
- All candidates with neurological disorders other than those attributed to their primary diagnosis (e.g., MS, PD, ALS, AD or other dementia, uncontrolled pain).
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- All candidates with a history of oral cancer.
- All candidates who have been treated for any type of cancer other than basal cell carcinoma within the past year.
- All candidates who have had a penetrating injury, craniotomy (with the exception of a burr hole [trephination] for resolution of acute subdural hematoma), or refractory subdural hematoma.
- Exceptions for other abnormalities identified in neuroradiologic scan reports that are asymptomatic and not expected to change may be made on a case by case basis by the Medical Advisor.
- All candidates with chronic use of psychoactive or psychostimulant medications that, in the opinion of the investigators, would compromise the subject's ability to comprehend and perform the study activities.
- All candidates who have a pacemaker, or are identified as at-risk for cardiovascular events.
- All candidates who are pregnant or lactating.
- All candidates with a lower extremity biomechanical prosthetic.
- All candidates with a history of seizures (except those in the acute or post-acute phases, and are controlled).
- All candidates who who experienced a loss of consciousness greater than 24 hours as a result of their TBI.
- All candidates with a "severe" score in any of the Attention, Memory, or Executive Functions categories on the Cognitive Linguistic Quick Test (CLQT).
- All candidates who, in the opinion of the investigators, are unable to feel the stimulation and successfully complete the device level setting procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
TCNL, Department of Kinesiology, UW Madison
Madison, Wisconsin, 53706
About this study
Official title: Cranial Nerve Noninvasive Neuromodulation Using the PoNS for Treatment of Symptoms Due to Mild or Moderate Traumatic Brain Injury
The investigators hypothesis is that electrical stimulation to the tongue that directly stimulates two cranial nerve nuclei (Trigeminal and Facial Nerve Nuclei), will excite neural impulses to the brainstem and cerebellum. The investigators call this cranial nerve non-invasive neuromodulation (CN-NINM). The activation of these structures induces neuroplasticity when combined with specific physical, cognitive and/or mental exercises, promoting recovery of selected functional damage such as problems with balance or walking.
44 subjects will be recruited for 2 weeks of intensive In-Lab Balance and Gait Training followed by 12 weeks of intensive Home Training with weekly In-Lab check sessions. Half of the subjects will use CN-NINM in conjunction with the exercise. Half of the subjects will use very low level stimulation in conjunction with the exercise, and will serve as a control group.
Read the detailed description
- Based on the results of the investigators pilot study in moderate traumatic brain injury (M-TBI), the investigators will conduct a randomized, controlled study of cranial nerve non-invasive neuromodulation (CN-NINM) in individuals with chronic symptoms of mild to moderate traumatic brain injury (mTBI), post-concussive sequelae, (PCS) and post-traumatic stress (PTS).
- The study will involve training of both balance and gait, with assessments using standardized and relevant metrics to monitor changes in these indications, as well as cognitive function, sleep, headache, anxiety, mood, and eye-movement control.
- The training regimen involves using a neurostimulation intervention that addresses primary and secondary symptoms associated with mTBI, PCS, and PTS.
- This randomized double blind controlled study will enroll a total of 44 subjects (M \& F) in 2 equal subgroups: 22 with an Active PoNS™, and 22 with a Control (non-zero, minimally perceivable stimulation) device.
- Subjects will participate in a 3-phase intervention beginning with a 2-week in-lab training program (ITP) (2 in-lab training sessions and 1 home training session daily), followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training). Subjects will return to the clinic weekly during the at-home phase for a single session of retraining and progression, and participate in periodic retesting.
- All training and testing will be performed uniformly across all subjects in both groups. Multiple assessment metrics will capture data at the beginning and end of the 2-week in-lab CN-NINM intervention period and at 3-week intervals. After completion of the formal training period, subjects will stop using the device (withdrawal stage) and will be tested every 3 weeks over an additional 12 weeks to monitor and assess changes due to withdrawal of the PoNS. This will yield a total of 10 data points for each subject.
- If successful, this study would indicate that CN-NINM may improve rehabilitation outcomes and reduce time required to improve function.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Balance and Gait Training using neurostimulation modulation., Sham Device
- Keywords
- Cranial Nerve Noninvasive Neuromodulation, Portable Neuromodulation Stimulator (PoNS), Balance and Gait Training, Breathing Awareness Training
- 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.
Balance and Gait Training using neurostimulation modulation.Device
Also called Cranial Nerve Non-invasive Neuromodulation (CN-NINM), Portable Neuromodulation Stimulator (PoNS)
CN-NINM uses sequenced patterns of electrical stimulation on the tongue. Our hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
Sham DeviceDevice
The sham device is visually identical to the CN-NINM device, and offers a non-zero, minimally perceivable stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Neurostimulation | Experimental | Balance and gait training using neurostimulation modulation. 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training). Receives: Device: Balance and Gait Training using neurostimulation modulation. |
| Minimally perceivable stimulation | Sham comparator | Balance and gait training using non-zero, minimally perceivable stimulation (sham device). 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training). Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
NeuroCom Computerized Dynamic Posturography Sensory Organization Test (SOT)
SOT assesses the ability to use visual, proprioceptive, and vestibular cues to maintain postural stability. Subjects stand on dual-force plates and the anterior-posterior sway is recorded. 6 conditions are tested (3, 20-sec trials each): Eyes open on firm surface; Eyes closed on firm surface; Eyes open with sway referenced visual surround; Eyes open on sway referenced support surface; Eyes closed on sway referenced support surface; Eyes open on sway referenced support surface and surround.
A composite score is generated by the NeuroCom BalanceMaster System using an algorithm to calculate the composite score from each of the 3 serial repetitions for each of the 6 conditions (a total of 18 sub-scores). The calculated composite score ranges from 0 to 100 points; 0 is complete failure, 100 is perfect stability, 70 is the lower limit normal. Group mean score for each time-point is reported.
Measured: Baseline, 2, 14, and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell E Tyler, MS, Principal investigator, TCNL, Department of Kinesiology, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158494
- Sponsor's protocol ID
- 2014-0002
- Status last verified
- Apr 2019
- First submitted
- 14 May 2014
- Last updated
- 3 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Individual participant data collected during the trial, after deidentification will be available to researchers for independent verification of study outcomes or to conduct subsequent clinical research, whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Nerve Noninvasive Neuromodulation Using the PoNS for Treatment of Symptoms Due to Mild or Moderate Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02158494
- Acronym / sponsor ID
- 2014-0002
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Cranial Nerve Noninvasive Neuromodulation, Portable Neuromodulation Stimulator (PoNS), Balance and Gait Training, Breathing Awareness Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Posted 3 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesis is that electrical stimulation to the tongue that directly stimulates two cranial nerve nuclei (Trigeminal and Facial Nerve Nuclei), will excite neural impulses to the brainstem and cerebellum. The investigators call this cranial nerve non-invasive neuromodulation (CN-NINM). The activation of these structures induces neuroplasticity when combined with specific physical, cognitive and/or mental exercises, promoting recovery of selected functional damage such as problems with balance or walking.
44 subjects will be recruited for 2 weeks of intensive In-Lab Balance and Gait Training followed by 12 weeks of intensive Home Training with weekly In-Lab check sessions. Half of the subjects will use CN-NINM in conjunction with the exercise. Half of the subjects will use very low level stimulation in conjunction with the exercise, and will serve as a control group.
Detailed description
- Based on the results of the investigators pilot study in moderate traumatic brain injury (M-TBI), the investigators will conduct a randomized, controlled study of cranial nerve non-invasive neuromodulation (CN-NINM) in individuals with chronic symptoms of mild to moderate traumatic brain injury (mTBI), post-concussive sequelae, (PCS) and post-traumatic stress (PTS).
- The study will involve training of both balance and gait, with assessments using standardized and relevant metrics to monitor changes in these indications, as well as cognitive function, sleep, headache, anxiety, mood, and eye-movement control.
- The training regimen involves using a neurostimulation intervention that addresses primary and secondary symptoms associated with mTBI, PCS, and PTS.
- This randomized double blind controlled study will enroll a total of 44 subjects (M \& F) in 2 equal subgroups: 22 with an Active PoNS™, and 22 with a Control (non-zero, minimally perceivable stimulation) device.
- Subjects will participate in a 3-phase intervention beginning with a 2-week in-lab training program (ITP) (2 in-lab training sessions and 1 home training session daily), followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training). Subjects will return to the clinic weekly during the at-home phase for a single session of retraining and progression, and participate in periodic retesting.
- All training and testing will be performed uniformly across all subjects in both groups. Multiple assessment metrics will capture data at the beginning and end of the 2-week in-lab CN-NINM intervention period and at 3-week intervals. After completion of the formal training period, subjects will stop using the device (withdrawal stage) and will be tested every 3 weeks over an additional 12 weeks to monitor and assess changes due to withdrawal of the PoNS. This will yield a total of 10 data points for each subject.
- If successful, this study would indicate that CN-NINM may improve rehabilitation outcomes and reduce time required to improve function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurostimulation | Experimental | Device: Balance and Gait Training using neurostimulation modulation.Balance and gait training using neurostimulation modulation. 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training). |
| Minimally perceivable stimulation | Sham comparator | Device: Sham DeviceBalance and gait training using non-zero, minimally perceivable stimulation (sham device). 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All candidates will have a balance disorder as a result of a traumatic brain injury (TBI).
- All candidates will have a NeuroCom® Sensory Organization Test (SOT) composite score at least 8 points below normal after adjustment for age and height [based on normative data].
- All candidates will be between the ages of 18 and 65 (at the time of screening).
- If female of childbearing potential, the candidate agrees to use adequate contraception throughout participation in the study (from enrollment to completion).
- All candidates must have access to a treadmill.
Key exclusion criteria (18 listed)
- All candidates that have oral health problems (e.g. gum disease, active cankers, piercings, oral surgery within the previous 3 months).
- All candidates with non-removable metal orthodontic devices (e.g., braces) or oral cavity piercings that could interfere with PoNS™ use.
- All candidates who have chronic infectious diseases (e.g. hepatitis, HIV, TB).
- All candidates with unmanaged hypertension.
- All candidates with unmanaged diabetes, or complications due to diabetes (e.g. retinopathy, neuropathy, renal disease).
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 |
|---|---|---|
| Balance and Gait Training using neurostimulation modulation.Also: Cranial Nerve Non-invasive Neuromodulation (CN-NINM), Portable Neuromodulation Stimulator (PoNS)CN-NINM uses sequenced patterns of electrical stimulation on the tongue. Our hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII. | Device | Neurostimulation |
| Sham DeviceThe sham device is visually identical to the CN-NINM device, and offers a non-zero, minimally perceivable stimulation. | Device | Minimally perceivable stimulation |
Primary outcome
NeuroCom Computerized Dynamic Posturography Sensory Organization Test (SOT)
Time frame: Baseline, 2, 14, and 26 weeks
SOT assesses the ability to use visual, proprioceptive, and vestibular cues to maintain postural stability. Subjects stand on dual-force plates and the anterior-posterior sway is recorded. 6 conditions are tested (3, 20-sec trials each): Eyes open on firm surface; Eyes closed on firm surface; Eyes open with sway referenced visual surround; Eyes open on sway referenced support surface; Eyes closed on sway referenced support surface; Eyes open on sway referenced support surface and surround. A composite score is generated by the NeuroCom BalanceMaster System using an algorithm to calculate the composite score from each of the 3 serial repetitions for each of the 6 conditions (a total of 18 sub-scores). The calculated composite score ranges from 0 to 100 points; 0 is complete failure, 100 is perfect stability, 70 is the lower limit normal. Group mean score for each time-point is reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- related infoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data collected during the trial, after deidentification will be available to researchers for independent verification of study outcomes or to conduct subsequent clinical research, whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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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.
Mitchell E Tyler, MS principal investigator
TCNL, Department of Kinesiology, University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance and Gait Training using neurostimulation modulation. in people with Brain Injuries, Traumatic, run by University of Wisconsin, Madison at 1 site in United States.
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 11 inclusion and 18 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 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 3 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
NeuroCom Computerized Dynamic Posturography Sensory Organization Test (SOT) (time frame: Baseline, 2, 14, and 26 weeks). 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 3 May 2019.