The Use of the PoNS™ Device in the Treatment of Blunt and Blast Induced Vestibular Disorders

Traumatic brain injury (TBI) is a major worldwide health issue. Figures from the Centers for Disease control show that 1.7 million people suffer a TBI annually. Meanwhile the World Health Organization recognizes TBI as one of the most significant health issues in developing countries. In the military, mild traumatic brain injury (mTBI) is one of the most frequent sequela of modern war. Dizziness and balance disorders are the most frequent sequela of mTBI and account for a significant degree of mTBI morbidity. At the current time, the best treatment modality for dizziness secondary to mTBI is vestibular rehabilitation (VR). While VR is effective, the therapy is time consuming, not universally successful, and results in incomplete recovery by many patients. Work needs to be done in an attempt to improve therapy outcomes. This project will study the use of neuromodulation (through stimulation of the tongue) as an adjuvant to improve the effectiveness of VR and reduce the time involved in VR. Given past work with variants on this minimal medical impact appliance, using the PoNS™ device to augment therapy may result in a significant improvement in VR outcomes. Given the enormous public health and military burden of mTBI, and given that dizziness is a major component often responsible for significant morbidity, this project has significant military and civilian impact and can be beneficial to those who suffer mTBI worldwide.

Study Overview

• Status: Withdrawn
• Conditions: Hearing and Vestibular Disorders
• Intervention / Treatment: Device: PoNS™ device; Other: Placebo device

Detailed Description

The CN-NINM intervention is an experimental regimen. It has been developed over the last 12 years at Tactile Communication and Neurorehabilitation Laboratory (TCNL) at the University of Wisconsin - Madison. All human subjects testing was performed under IRB approval. The PoNS™ is an experimental device that has been evolved over this same period at TCNL, and is not FDA approved. An Investigator's Brochure and attendant Safety Chart have been developed to satisfy requirements for an Investigational Device Exemption, and provide additional context with respect to the research proposed here.

The goal of this work is to test the effectiveness of this device with standard rehabilitation therapy on individuals who have operationally induced balance disorders from blunt or blast head trauma.

SPECIFIC OBJECTIVES:

1. To compare the effectiveness of active PoNS-2 (PoNS™) device combined with standard vestibular rehabilitation to a placebo PoNS™ device with vestibular rehabilitation in patients with blast and blunt head trauma induced dizziness over the time period of a standard course of therapy.
2. To compare the effectiveness of active PoNS™ device combined with standard vestibular rehabilitation to a placebo PoNS™ device with vestibular rehabilitation in patients with blast and blunt head trauma induced dizziness three months after a standard course of rehabilitation.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Head Injury from blunt or blast suffered within the lines of duty
• Not meeting any of the exclusion criteria
• Injury occurred 21 -365 days ago

Exclusion Criteria:

• History of a diagnosed balance disorder prior to injury
• Going through board process before starting participation
• Significant medical issues including but not limited to heart disease, pulmonary disease, autoimmune disorders, severe arthritis, etc.
• Orthopedic injuries that prevent standing and walking
• Age less than 18 or greater than 40 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; PoNS™ device	Device: PoNS™ device; The PoNS™ device uses electrotactile waveform in conjunction with the Cranial Nerve - Non-Invasive NeuroModulation (CN-NINM) intervention. This involves using both balance and gait training methods to stabilize symptoms, regain balance & gait, and affect the functional transfer of improved stability and mobility to activities of daily living. It is based on a body of work focused on developing the tongue-based human-machine interface and application of this technology for balance, vision, and auditory substitution and more recently as neuromodulation for brain rehabilitation after injury and disease.; Other Names: Portable Neuromodulation Stimulator, version 2.2
Placebo Comparator: Placebo Arm; placebo device	Other: Placebo device; Placebo device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sensory Organization Test score	Posturography for Sensory Organization Test: Utilizing a computerized dynamic posturography (Neurocom Inc., Clackmas, OR) the sensory organization test (SOT) is conducted by measuring postural sway on a force plate under six different conditions as follows 1) Normal Stance eyes open, 2) Normal Stance with eyes closed, 3) Normal Stance with sway referenced visual surround, 4) Sway reference stance eyes open, 5) Sway reference stance with eyes closed, and 6) Sway reference stance with sway referenced vision. The SOT will conduct three trials in each condition and utilize the information to produce a computer generated objective score of balance/posture function. The exam takes less than ten minutes to produce.	Change from Baseline SOT score at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Vestibular-Ocular Reflex scores	VOR Tests: A Neuro Kinetics IPortal Video-oculography system (Neurokinetics Inc., Pittsburgh, PA) with a six degree of freedom accelerometer will be used to (1) document head thrust test findings qualitatively and (2) provide objective measurements of test results. The software will be configured for (1) detection of head thrusts of appropriate direction and orientation (re: earth vertical) and (2) real-time determination of performance parameters (VOR).	Change from Baseline VOR score at 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Gait Assessment Test scores	The Functional Gait Assessment Test (FGAT) is a 10 item gait task test in which each task is graded on a 0-3 scale with 0 indicating could not perform and 3 indicating performed without error. Grading is done by an experienced rater. The FGAT produces an ordinal score on a 0-30 point scale and is normed from previous civilian and military studies.	Change from Baseline FGAT score at 3 months
Change in Dizziness Handicap Index scores	The Dizziness Handicap Index (DHI) is a well-validated self report the produces a score on a hundred-point scale.	Change from Baseline DHI score at 3 months
Change in Activities specific Balance Confidence scale scores	The Activities specific Balance Confidence scale (ABC) is a 16 question survey in which individuals' answer how confident they are about being able to perform a balance related task on a 0%-100% scale. The questionnaire is scored by adding the percentages and dividing by 100% to arrive at a scaled score form 0-100.	Change from Baseline ABC score at 3 months

Collaborators and Investigators

• Sponsor: United States Naval Medical Center, San Diego
• Collaborators: The Geneva Foundation
• Investigators: Principal Investigator: Michael E. Hoffer, M.D., United States Naval Medical Center, San Diego

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: January 14, 2013
• First Submitted That Met QC Criteria: January 16, 2013
• First Posted (Estimate): January 18, 2013

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Vestibular Diseases; Ear Diseases
• Other Study ID Numbers: NMCSD.2013.0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No