Clinical trial NCT01771575: The Use of the PoNS™ Device in the Treatment of Blunt and Blast Induced Vestibular Disorders
Official title: The Use of the PoNS™ Device in the Treatment of Blunt and Blast Induced Vestibular Disorders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hearing and Vestibular Disorders
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: The Geneva Foundation
First posted: 2013-01-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Sensory Organization Test score
timeFrame: Change from Baseline SOT score at 3 months
Secondary outcomes:
measure: Change in Vestibular-Ocular Reflex scores
timeFrame: Change from Baseline VOR score at 3 months
Other outcomes:
measure: Change in Functional Gait Assessment Test scores
timeFrame: Change from Baseline FGAT score at 3 months
measure: Change in Dizziness Handicap Index scores
timeFrame: Change from Baseline DHI score at 3 months
measure: Change in Activities specific Balance Confidence scale scores
timeFrame: Change from Baseline ABC score at 3 months
Locations:
city: San Diego
country: United States
facility: Naval Medical Center, San Diego
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Michael E. Hoffer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: