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

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Hearing and Vestibular Disorders

In brief

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.

Key facts

Study ID

NCT01771575

Run by

United States Naval Medical Center, San Diego

People needed

0

Starts

2013-07-01

Expected to finish

2014-09-01

Last updated by the study team

2020-09-10

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.