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

NCT ID: NCT01771575

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-09-30

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.

Conditions

Hearing and Vestibular Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment Arm

PoNS™ device

Group Type: EXPERIMENTAL

PoNS™ device

Intervention Type: 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.

Placebo Arm

placebo device

Group Type: PLACEBO_COMPARATOR

Placebo device

Intervention Type: OTHER

Placebo device

Interventions

Placebo device

Placebo device

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Other Intervention Names

Portable Neuromodulation Stimulator, version 2.2

Eligibility Criteria

Inclusion Criteria

• Head Injury from blunt or blast suffered within the lines of duty

Exclusion Criteria

• Injury occurred 21 -365 days ago

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Geneva Foundation

OTHER

Sponsor Role: collaborator

United States Naval Medical Center, San Diego

FED

Sponsor Role: lead

Responsible Party

Sara Murphy

Research Administrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael E. Hoffer, M.D.

Role: PRINCIPAL_INVESTIGATOR

United States Naval Medical Center, San Diego

Locations

Naval Medical Center, San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

NMCSD.2013.0011

Identifier Type: -

Identifier Source: org_study_id