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

Not Applicable

Withdrawn

• Conditions: Hearing and Vestibular Disorders
• Interventions: Other: Placebo device; Device: PoNS™ device

• Registration Number: NCT01771575
• Lead Sponsor: United States Naval Medical Center, San Diego

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Study Start: 2013-07
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo device	placebo device
Treatment Arm	PoNS™ device	PoNS™ device

Primary Outcome Measures

Name	Time	Method
Change in Sensory Organization Test score	Change from Baseline SOT score at 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Vestibular-Ocular Reflex scores	Change from Baseline VOR score at 3 months	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).

Trial Locations

Locations (1)

Naval Medical Center, San Diego; 🇺🇸 San Diego, California, United States