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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balance and Gait Training using neurostimulation modulation. | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2, 14, and 26 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Neurobehavioral Symptom Inventory Over Baseline | A 22-item subjective inventory of TBI symptoms where symptoms are scored on a scale of 0 (none) to 4 (very severe). Lower scores indicate decreased symptoms. Group mean change from baseline at 2, 14, and 26 weeks is reported. The range of possible scores if from 0 to 88. The results are reported as a change from baseline. | Change from Baseline at 2,14, and 26 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell E Tyler, MS | TCNL, Department of Kinesiology, University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TCNL, Department of Kinesiology, UW Madison | Madison | Wisconsin | 53706 | United States |
Not provided
| Label | URL |
|---|---|
| related info | View source |
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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.
Beginning 9 months after publication of primary outcomes, and ending 5 years after that date.
Proposals should be directed to metyler1@wisc.edu. If approved after review by regulatory counsel, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.
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13 subjects provided consent but did not enroll in the study at sites under UW-Madison purview.
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| ID | Title | Description |
|---|---|---|
| FG000 | Neurostimulation | 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) |
| FG001 | Control (Non-zero, Minimally Perceivable Stimulation) | Balance and gait training using non-zero, minimally perceivable stimulation. 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neurostimulation | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 14, and 26 weeks |
|
26 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neurostimulation | 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). Balance and Gait Training using neurostimulation modulation.: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders and administration site conditions - Other, specify | General disorders | Systematic Assessment | Subject became nauseous, with a high fever and impaired balance.Responders brought her to the hospital. She was admitted, assessed and treated. No definite cause for her symptoms was identified. All symptoms have resolved and there was no recurrence. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General Pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mitchell Tyler | University of Wisconsin - Madison | 608-262-5112 | metyler1@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 13, 2016 | Sep 29, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 5, 2016 | Sep 29, 2017 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
|
| Sham Device | Device | The sham device is visually identical to the CN-NINM device, and offers a non-zero, minimally perceivable stimulation. |
|
| Change in 6-Minute Walk Test (6MWT) Over Baseline | Measures walking speed over ground. The six-minute walk test (6MWT) measures the distance in meters an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. Change in 6MWT over baseline for each time point is reported. | Change from Baseline at 2,14, and 26 weeks |
| Change in Dynamic Gait Index (DGI) Over Baseline | Assesses walking, walking with head turns, over and around obstacles, and stairs. Dynamic Gait Index - A semiquantitative tool used to evaluate a patient's ability to modify gait by changing task demands, esp. in patients with dizziness and balance deficits. This test is used to identify patients, esp. older adults, who are predisposed to falling. Participants are graded from 0 (low function) to 3 (high function) on 8 tasks: normal walking, their ability to vary walking speed, turn their heads, turn their bodies, step over and around obstacles, climb stairs, turn while walking. The range of scores is 0-24, higher scores indicate higher function, with a score of 24 considered Normal. Change from baseline to 2, 14, and 26 weeks is reported. | Change from Baseline at 2,14, and 26 weeks |
| Change in California Verbal Learning Test (CVLT) Over Baseline | Assesses short- and long-term verbal memory by evaluating a series of recall and recognition tasks. The test is scored via computer algorithm. A score of 50 represents is equal to the population mean, the normal range is between 40-60 (ie. +/- 1 SD from the mean). The total range of possible scores is 0 (no recalled words) to 100 (all correct). Change in score over baseline at 2, 14, and 26 weeks is reported. | Change from Baseline at 2,14, and 26 weeks |
| Change in Brief Symptom Inventory 18 (BSI 18) Over Baseline | A short, reliable, 18-question instrument for assessment of psychological distress (anxiety, depression, & somatization) in a clinical population. It is scored from 0-4, with a total range of possible scores 0-72 where higher scores indicate more distress. | Change from Baseline at 2,14, and 26 weeks |
| Change in Wechsler Adult Intelligence Scale - Symbol Search and Coding (WAIS-IV) Over Baseline | Assesses visual spatial abilities. The Symbol Search and Coding WAIS-IV subtests measure Processing Speed, an indicator of the rate of cognitive processing and creating an appropriate response output. The tasks require attending to visual material, visual scanning and perception, spatial organization, hand-eye coordination, and paired associative learning. The raw score (processing speed for each test) is converted to a scaled score 1-10 for each and summed for a total possible score of 2-20, the higher the score, the more improved the processing speed. Change in score from baseline to 2, 14, and 26 weeks are reported. | Change from Baseline at 2,14, and 26 weeks |
| Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline | Subjective inventory of sleep habits, duration and quality. It is scored from 7 components (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction) to provide a global PSQI score. Most items are scored from 0-3 where 3 is a negative extreme, therefore lower cumulative scores are indicative of improved sleep habits. The total range of scores is from 0-21. | Baseline at 2,14, and 26 weeks |
| Change in Headache Disability Index (HDI) From Baseline | Assesses frequency & severity of headaches via a 25-item questionnaire where an answer of 'yes' = 4 points, 'sometimes' = 2 points, and 'no' = 0 points. The lower the score, the less frequent and severe the symptoms. The range of possible scores is 0 to 100. The results are reported as a change from baseline. | Change from Baseline at 2,14, and 26 weeks |
| Electromyography (EMG) | Measures muscle activation patterns during gait. | Change from Baseline at 2,14, and 26 weeks |
| Computerized Video Nystagmography (VNG) | Measures eye movement control under 3 static (x and y axis fixation, spontaneous nystagmus), and 3 dynamic conditions (random saccade, smooth pursuit, optokinetic nystagmus). | Change from Baseline at 2,14, and 26 weeks |
| Control (Non-zero, Minimally Perceivable Stimulation) |
Balance and gait training using non-zero, minimally perceivable stimulation. 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Neurostimulation |
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. |
| OG001 | Control (Non-zero, Minimally Perceivable Stimulation) | 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. |
|
|
|
| Other Pre-specified | Change in Neurobehavioral Symptom Inventory Over Baseline | A 22-item subjective inventory of TBI symptoms where symptoms are scored on a scale of 0 (none) to 4 (very severe). Lower scores indicate decreased symptoms. Group mean change from baseline at 2, 14, and 26 weeks is reported. The range of possible scores if from 0 to 88. The results are reported as a change from baseline. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline at 2,14, and 26 weeks |
|
|
|
| Other Pre-specified | Change in 6-Minute Walk Test (6MWT) Over Baseline | Measures walking speed over ground. The six-minute walk test (6MWT) measures the distance in meters an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. Change in 6MWT over baseline for each time point is reported. | Posted | Mean | Standard Deviation | meters | Change from Baseline at 2,14, and 26 weeks |
|
|
|
| Other Pre-specified | Change in Dynamic Gait Index (DGI) Over Baseline | Assesses walking, walking with head turns, over and around obstacles, and stairs. Dynamic Gait Index - A semiquantitative tool used to evaluate a patient's ability to modify gait by changing task demands, esp. in patients with dizziness and balance deficits. This test is used to identify patients, esp. older adults, who are predisposed to falling. Participants are graded from 0 (low function) to 3 (high function) on 8 tasks: normal walking, their ability to vary walking speed, turn their heads, turn their bodies, step over and around obstacles, climb stairs, turn while walking. The range of scores is 0-24, higher scores indicate higher function, with a score of 24 considered Normal. Change from baseline to 2, 14, and 26 weeks is reported. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline at 2,14, and 26 weeks |
|
|
|
| Other Pre-specified | Change in California Verbal Learning Test (CVLT) Over Baseline | Assesses short- and long-term verbal memory by evaluating a series of recall and recognition tasks. The test is scored via computer algorithm. A score of 50 represents is equal to the population mean, the normal range is between 40-60 (ie. +/- 1 SD from the mean). The total range of possible scores is 0 (no recalled words) to 100 (all correct). Change in score over baseline at 2, 14, and 26 weeks is reported. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline at 2,14, and 26 weeks |
|
|
|
| Other Pre-specified | Change in Brief Symptom Inventory 18 (BSI 18) Over Baseline | A short, reliable, 18-question instrument for assessment of psychological distress (anxiety, depression, & somatization) in a clinical population. It is scored from 0-4, with a total range of possible scores 0-72 where higher scores indicate more distress. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline at 2,14, and 26 weeks |
|
|
|
| Other Pre-specified | Change in Wechsler Adult Intelligence Scale - Symbol Search and Coding (WAIS-IV) Over Baseline | Assesses visual spatial abilities. The Symbol Search and Coding WAIS-IV subtests measure Processing Speed, an indicator of the rate of cognitive processing and creating an appropriate response output. The tasks require attending to visual material, visual scanning and perception, spatial organization, hand-eye coordination, and paired associative learning. The raw score (processing speed for each test) is converted to a scaled score 1-10 for each and summed for a total possible score of 2-20, the higher the score, the more improved the processing speed. Change in score from baseline to 2, 14, and 26 weeks are reported. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline at 2,14, and 26 weeks |
|
|
|
| Other Pre-specified | Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline | Subjective inventory of sleep habits, duration and quality. It is scored from 7 components (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction) to provide a global PSQI score. Most items are scored from 0-3 where 3 is a negative extreme, therefore lower cumulative scores are indicative of improved sleep habits. The total range of scores is from 0-21. | Posted | Mean | Standard Deviation | score on a scale | Baseline at 2,14, and 26 weeks |
|
|
|
| Other Pre-specified | Change in Headache Disability Index (HDI) From Baseline | Assesses frequency & severity of headaches via a 25-item questionnaire where an answer of 'yes' = 4 points, 'sometimes' = 2 points, and 'no' = 0 points. The lower the score, the less frequent and severe the symptoms. The range of possible scores is 0 to 100. The results are reported as a change from baseline. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline at 2,14, and 26 weeks |
|
|
|
| Other Pre-specified | Electromyography (EMG) | Measures muscle activation patterns during gait. | Not Posted | Change from Baseline at 2,14, and 26 weeks | Participants |
| Other Pre-specified | Computerized Video Nystagmography (VNG) | Measures eye movement control under 3 static (x and y axis fixation, spontaneous nystagmus), and 3 dynamic conditions (random saccade, smooth pursuit, optokinetic nystagmus). | Not Posted | Change from Baseline at 2,14, and 26 weeks | Participants |
| 0 |
| 22 |
| 3 |
| 22 |
| 11 |
| 22 |
| EG001 | Minimally Perceivable Stimulation | Balance and gait training using non-zero, minimally perceivable stimulation. 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). Balance and Gait Training using neurostimulation modulation.: 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. | 0 | 21 | 1 | 21 | 8 | 21 |
|
| Gallbladder Obstruction | Hepatobiliary disorders | Systematic Assessment | Subject was admitted to the hospital with abdominal pain and had an ultrasound of his gall bladder that showed gall stones in the gall bladder. He had surgery to remove his gall bladder. He was discharged and was given oxycodone for pain management. |
|
| Urinary Tract Obstruction | Renal and urinary disorders | Systematic Assessment | Subject reported that he had kidney stones. He was in the hospital for 6 days due to the kidney stones. He went into septic shock. He was treated with IV antibiotics and a stent was placed. Extracorporeal shock wave lithotripsy was scheduled. |
|
| Prostate cancer | Renal and urinary disorders | Serious Adverse Even | Systematic Assessment | During end of study wrap up, subject reported that he had been diagnosed with prostate cancer on 11 Feb 2016. He is under the care of an oncologist and was scheduled for surgery |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Poisoning | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Surgery | Surgical and medical procedures | Systematic Assessment |
|
| Kidney Stones | Renal and urinary disorders | Systematic Assessment |
|
| Diabetic Shock | Metabolism and nutrition disorders | Systematic Assessment |
|
| Vomiting and Diahrrea | Gastrointestinal disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| Week 26 |
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