This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Noninvasive Neuromodulation for Treatment of Symptoms Due to Mild or Moderate Traumatic Brain Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT02158494
First received: May 14, 2014
Last updated: June 14, 2017
Last verified: June 2017
  Purpose

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.


Condition Intervention
Brain Injuries, Traumatic Device: Balance and Gait Training using neurostimulation modulation.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: Cranial Nerve Noninvasive Neuromodulation Using the PoNS for Treatment of Symptoms Due to Mild or Moderate Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • NeuroCom Computerized Dynamic Posturography Sensory Organization Test (SOT) [ Time Frame: Change from Baseline at 2, 5, 8, 11, 14, 17, 20, 23 and 26 weeks ]
    Measures standing dynamic balance.


Other Outcome Measures:
  • Neurobehavioral Symptom Inventory [ Time Frame: Change from Baseline at 2,14, and 26 weeks ]
    Subjective inventory of TBI symptoms.

  • 6-Minute Walk Test (6MWT) [ Time Frame: Change from Baseline at 2, 5, 8, 11, 14, 17, 20, 23, and 26 weeks ]
    Measures walking speed over ground.

  • Dynamic Gait Index (DGI) [ Time Frame: Change from Baseline at 2, 5, 8, 11, 14, 17, 20, 23, and 26 weeks ]
    Assesses walking, walking with head turns, over and around obstacles, and stairs.

  • Physiologic Stress Test [ Time Frame: Change from Baseline at 2,14, and 26 weeks ]
    Measures resting & post exercise heart rate, respiration, skin conductance, and skin temperature.

  • California Verbal Learning Test (CVLT) [ Time Frame: Change from Baseline at 2,14, and 26 weeks ]
    Assesses short- and long-term verbal memory.

  • Brief Symptom Inventory 18 (BSI 18) [ Time Frame: Change from Baseline at 2,14, and 26 weeks ]
    Assesses anxiety symptoms.

  • Wechsler Adult Intelligence Scale - Symbol Search and Coding (WAIS-IV) [ Time Frame: Change from Baseline at 2,14, and 26 weeks ]
    Assesses visual spatial abilities.

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Change from Baseline at 2,14, and 26 weeks ]
    Subjective inventory of sleep habits, duration and quality.

  • Headache Disability Index (HDI) [ Time Frame: Change from Baseline at 2,14, and 26 weeks ]
    Assesses frequency & severity of headaches.

  • Electromyography (EMG) [ Time Frame: Change from Baseline at 2,14, and 26 weeks ]
    Measures muscle activation patterns during gait.

  • Computerized video nystagmography (VNG) [ Time Frame: Change from Baseline at 2,14, and 26 weeks ]
    Measures eye movement control.


Estimated Enrollment: 44
Study Start Date: May 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Device: 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.
Other Names:
  • Cranial Nerve Non-invasive Neuromodulation (CN-NINM)
  • Portable Neuromodulation Stimulator (PoNS)
Sham Comparator: 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).
Device: 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.
Other Names:
  • Cranial Nerve Non-invasive Neuromodulation (CN-NINM)
  • Portable Neuromodulation Stimulator (PoNS)

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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).
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02158494

Locations
United States, Wisconsin
TCNL, Department of Kinesiology, UW Madison
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Mitchell E Tyler, MS TCNL, Department of Kinesiology, University of Wisconsin, Madison
  More Information

Additional Information:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02158494     History of Changes
Other Study ID Numbers: 2014-0002
Study First Received: May 14, 2014
Last Updated: June 14, 2017

Keywords provided by University of Wisconsin, Madison:
Cranial Nerve Noninvasive Neuromodulation
Portable Neuromodulation Stimulator (PoNS)
Balance and Gait Training
Breathing Awareness Training

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 24, 2017