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

N

Naval Medical Center

Status

Withdrawn

Conditions

Hearing and Vestibular Disorders

Treatments

Other: Placebo device
Device: PoNS™ device

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01771575
NMCSD.2013.0011

Details and patient eligibility

About

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.

Full 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: 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. 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.

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups, including a placebo group

Treatment Arm
Experimental group
Description:
PoNS™ device
Treatment:
Device: PoNS™ device
Placebo Arm
Placebo Comparator group
Description:
placebo device
Treatment:
Other: Placebo device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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