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

NCT02158494 | Completed Results DMC

• 1 other identifier: 2014-0002
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Brain Injuries, Traumatic

Keywords

Cranial Nerve Noninvasive Neuromodulation; Portable Neuromodulation Stimulator (PoNS); Balance and Gait Training; Breathing Awareness Training

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (10)

• Change in Neurobehavioral Symptom Inventory Over Baseline

  Change from Baseline at 2,14, and 26 weeks

• Change in 6-Minute Walk Test (6MWT) Over Baseline

  Change from Baseline at 2,14, and 26 weeks

• Change in Dynamic Gait Index (DGI) Over Baseline

  Change from Baseline at 2,14, and 26 weeks

Study Arms (2)

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).

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).

Device: Sham Device

Interventions

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.

Also known as: Cranial Nerve Non-invasive Neuromodulation (CN-NINM), Portable Neuromodulation Stimulator (PoNS)

Neurostimulation

Sham Device DEVICE

The sham device is visually identical to the CN-NINM device, and offers a non-zero, minimally perceivable stimulation.

Minimally perceivable stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

TCNL, Department of Kinesiology, UW Madison

Madison, Wisconsin, 53706, United States

Location

Related Links

• related info

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Mitchell Tyler
• Organization: University of Wisconsin - Madison

metyler1@wisc.edu

608-262-5112

Study Officials

• Mitchell E Tyler, MS

  TCNL, Department of Kinesiology, University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: June 6, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: October 1, 2017
• Last Updated: May 3, 2019
• Results First Posted: May 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning 9 months after publication of primary outcomes, and ending 5 years after that date.
• Access Criteria: 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.

Locations

US (1)